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Maltese Laws |
MEDICINES ACT
To make provision for matters connected with the manufacture, preparation and assembly, wholesale distribution, storage, destruction, disposal, advertising and authorisation of medicinal products and any activity connected therewith and the regulation of the sale of medicinal products, pharmacies and related pharmaceutical activities and for any other matters ancillary thereto or connected therewith.
21st November, 2003;
1st December, 2003
ACT III of 2003, as amended by Acts III of 2004 and XI of 2007; Legal Notice 427 of 2007;
and Act XXIX of 2007.
ARRANGEMENT OF ACT
Articles
1
Part I Preliminary 2
Part II Administration 3 - 18
Title I Licensing Authority 3
Title II The Medicines Authority 4 - 13
Title III Medicines Review Board 14 - 18
Part III General Provisions 19 - 89
Title I Marketing authorisation relating to Medical Products 19 - 36
Title II Manufacture of Medical Products for Human Use 37 - 53
Title III Wholesale Distribution of Medicinal Products for
Human Use 54 - 65
Title IV Pharmacies and related Pharmaceutical Activity 66 - 89
Part IV Poisonous Substances 90 - 96
Part V Other dealings with Medicinal Products 97 - 98
Part VI Offences and Penalties 99 - 100
Part VII Enforcement 101 - 104
Part VIII Miscellaneous Provisions 105 - 109
First Schedule - Panel of experts to sit on Medicines Review
Board
Second Schedule- Proceedings of the Medicines Review Board
Third Schedule - Conditions and criteria where any person can have or not have a direct or indirect interest in a pharmacy
Short title. | 1. | The short title of this Act is the Medicines Act. |
PART I | ||
Interpretation. | 2. | PRELIMINARY In this Act, unless the context otherwise requires - |
Amended by:
III. 2004.44;
XI. 2007.2.
"advertising" in relation to medicinal products includes any form of door-to-door information, canvassing activity or inducement
designed to promote the prescription, supply, sale or consumption of medicinal products and without prejudice to the generality of
the foregoing in particular includes:
(a) the advertising of medicinal products to the general public;
(b) the advertising of medicinal products to persons qualified to prescribe or supply them;
(c) visits by medical or sales representatives to persons qualified to prescribe medicinal products;
(d) the supply of samples;
(e) the provision of inducements to prescribe or supply medicinal products, by way of a gift, offer or promise of any benefit or
bonus, whether in money or in kind, except when the intrinsic value of such an inducement is minimal;
(f) sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products;
(g) sponsorship of any scientific congress attended by persons qualified to prescribe or supply medicinal products and
in particular where payment of their travelling and accommodation expenses is offered in connection therewith;
but shall exclude:
(i) the labelling and the accompanying package leaflets, as may be specified in accordance with the provisions of Part III,
Title I of this Act;
(ii) correspondence, even if accompanied by material of a non-promotional nature, which is in reply to a specific question
about a particular medicinal product;
(iii) factual, informative, announcement or reference material relating to pack changes, adverse- reaction warnings
as part of general drug precautions, trade catalogues, price lists and other material of a similar nature provided
that such material does not include any product claim;
(iv) any statement relating to human health or disease, provided there is no reference, whether direct or indirect,
to a medicinal product;
"adv erse react i o n " m e ans a respo n se t o a medi ci nal pr odu ct w h i c h i s n o x i o u s an d un int e nd ed
an d w h i c h occurs at d o ses normally used in man for the prophylaxis, diagnosis or therapy of d i sease o r for t h e resto
r at ion, correct ion or mod i ficat i on of physiological function;
"analysis" includes testing of a medicinal product or any of its constituents, both active or inactive, in respect of their
chemical, physical, pharmaceutical, biol ogical, toxicological or pharmacological properties;
"assemble", in relation to a medicinal product, means to enclose the product in a container which is labelled before the
product is sold or supplied, or, where the product is already enclosed in the co ntainer in w h ich i t is to be sold or supp lied,
labelli ng t h e container before the product is sold or supplied in it, and shall also include the act of introducing approved information
in or on the container and "assembly" shall be construed accordingly;
"authorised officer" in relation to the Medicines Authority means any o fficer o r emp l oy ee o f t h e A u th ori t y
or an y oth e r perso n authorised by the Authority to act on its behalf and in relation to the Licensing Authority means an y offi
cer or em pl oyee of th e Department as referred to in article 5 of the Department of Health (Constitution) Ordinance authorised by the Licensing Authority to act on its behalf;
"business" means any economic activity whether carried out by the i ndiv i du al or by a bo dy of persons, wh ether corp
orat e or unincorporate and includes the exercise of a profession;
"clinical trial" means any i nvestigation in human subjects intended to discover or verify, the clinical, pharmacological
and, or other pharmacodynamic effects of on e or more investigati onal medicinal products, and, or to identify any adverse reactions
to one or more investigational medicinal products, and, or to study the absorption, distribution, metabolism and excretion of one
or more investigational products with the object of ascertaining their safety and, or efficacy. This includes clinical trials carried
out in either one site or multiple sties, whether in one or more than one Member State;
"common name" means the international non-proprietary name recommended by the World Health Organization, or, if one does
not exist, the usual common name;
"comp o siti on" i n relatio n t o a m e di ci nal pro duct, m eans th e ingredients constituting it and the proportions,
and the degrees of st reng th, qu alit y and pu rit y, in wh ich th ose i ngr ed ient s are respectively contained in it and as may
be established in a recognised pharmacopoeia;
"cont ai ner" in rel a tio n t o a medi cinal produ ct, m eans th e immediate packaging or outer packaging;
"cosmetic product" shall have the same definition as found under the Product Safety Act;
Cap. 94.
Cap. 427.
Cap. 31.
" d en ta l pr ac ti ti o n er " means a person who is authorised to exercise such profe s sion under the M e dical and Kindred Professions Ordinance or any other law replacing the same;
"disease" includes a n y injury, ailment or adverse c o ndition, whether of body or mind;
"dispensing" includes sale or supply of medicinal products;
Cap. 449. "foodstuff" shall have the same meaning as that under the Food
Safety Act;
"good practice" in relation to manufacturing practice, laboratory practic e, distribu tion practice, clinical prac tice
and dispensing practice means the stand a r d s for th e prop er execu tion of th e relative activity as established by or under
this Act;
"h er bal medicin a l pr odu ct" means any medicin a l pro duct, exclusively containing as active ingredients one or more
herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such
herbal preparations;
"herbal preparations" means preparations obtained by subjecting her bal substances to treatment s such as extr acti on,
distillatio n, exp r ession, fractio natio n, purifi c at ion, con centrat ion or ferm entation. These include comm inuted or powdered
herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates;
"herbal substances" means all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed,
usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered
to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial
system (genus, species, variety and author);
"homeopathic medicinal product" means any medicinal product prepared form substances called homeopathic stocks in accordance
with a homeopathic manu facturing proc edure described by the Europ e an Pharmaco poeia o r, in the absence the r eof, by the pharmacopoeias
currently used officially in the Member States. A homeo pathi c medici nal p r oduct may conti a n a number of principles;
"im mediate packagin g" mean s th e container or other form of packaging immediately in contact with the medicinal product;
"i mm uno log i cal medi cinal produ ct" m eans an y m e dici nal product consisting of vaccines, toxins, serums or allergen
products, where -
(a) vaccines, toxins and serums shall cover in particular:
(i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine;
(ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin
PPD, toxins for the Schick and Dick Tests, brucellin;
(iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin;
(b) "allergen product" shall mean any medicinal product which is intended to identify or induce a specific acquired
alteration in the immunological response to an allergizing agent;
"ingredient" in relation to the manufacture or the preparation of a substance, includes anything which is the sole active
ingredient of the substance as manufactured or prepared;
"i n v estigational medicinal product" means a pharmaceutical form of an active substance or placebo being tested or used
as a r e f e r e n c e in a cli n i c al tr ial, in cl ud in g p r o duct s already with a ma rk eti n g au th oriza tio n bu t used
o r assem b l e d (fo r m u lat e d or packaged) in a way different from the authorised form, or when used for an unauthorised indication,
or when used to gain further information about the authorised form;
"kit" means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually
prior to its administration;
"labelling" means any information on the im mediate or outer packaging;
"licence" means a licence issued under the provisions of this Act; "licensee" means any person who is the holder
of a licence for a
particular activity granted under this Act;
"magistral formula" means any medicinal product prepared in a p h armacy in acco r dance with a med i cal prescrip tio
n fo r an individual patient;
"manufacture", in relation to a medicinal product, includes any process carried out in the course of manufacturing the product,
but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle
for the purpose of administering it;
" m edical practitioner" means a person who is authorised to exercis e suc h profession under the Medical and Kindred Professions Ordinance or any other law replacing same;
"medicinal prescription" mean s any medicinal prescripti on issued by a professional person qualified to prescribe medicinal
products by or under this Act;
"medicin al product" means any substance or combination of substances -
(a) presented as having properties for treating or preventing disease in human beings; or
(b) which may be used in or administered to human beings either with a view to restoring, correcting or
Cap. 31.
modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical
diagnosis;
"m edicinal p r odu ct s derived fro m hu man b l ood or h u man plasm a" means m edicinal products based on blood constituents
which are prepared industrially by public or private establishments, su ch medi cin a l prod uct s includi ng, in particular , alb
u min, coagulating factors and immunoglobulins of human origin;
"medicinal purpose" includes any one or more of the following purposes:
(a) the treating or preventing disease;
(b) the diagnosing of disease or ascertaining the existence, degree or extent of a physiological condition;
(c) contraception;
(d) inducing anaesthesia;
(e) the prevention or interference with the normal operation of a physiological function, whether permanently
or temporarily, and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that
function or in any other way.
"Medicines Authority" means the Authority established under article 4;
"Medicines Review Board" means the Board established under article 14;
"Minister" means the Minister responsible for public health;
"name of the medicinal product" means the name, which may be either an invented name not liable to confusion with the common
name, or a common or scientific name accompanied by a tr ade mark or the name of the marketing authorisation holder;
"of f icinal formula" means any med i cinal produ ct wh ich is prepared in a pharmacy in accordance with the prescriptions
of a ph armacopo eia and is i n tended t o be suppl ied di rectly t o the patients served by such pharmacy;
"outer packaging" means th e pa ckaging into which the immediate packaging is placed;
"package", in relation to any medicinal product, means any box, packet or ot her article in whi c h o n e o r more container
of th e product are, or are intended to be, enclosed, and, where any such box, packet or other article is, or is to be itself enclosed
in one or m o re other boxes, packets or ar ticles, includes any of the said boxes, packets or articles;
"package leaflet" means a leaflet containing information for the user which accompanies the medicinal product;
"pharmacist" means a person who is authorised to exercise such profession under the Medical and Kindred Professions Ordinance, or any other law replacing the same;
"pharmacy technician" means a person authorised to act as such under the Medical Kindred and Profession Ordinance or any other law replacing the same;
"p re scri be d" m e an s p r esc r ib ed by re gu l a t i o n s m a de b y t h e
Minister under this Act;
"qualified person" means any person who is a qualified person in relation to a manufacturer ’s licence as provided in
article 38 (1)(e);
"radionuclide generator" means any system incorporating a fixed p a ren t radio nuclid e from whi c h is produ ced
a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical;
"radi onuclide precursor" means any radionuclide not b ein g a radio pharmaceu tical, radio nuclid e generato r or k it
wh ich is p r o duced for th e radio-labelli ng of another sub s tance prior t o administration;
"radio pharmaceuti cal " means any medicinal product which, w h en ready for use, co ntain s one o r mor e rad i
on uclides (radioactive isotopes) included for a medicinal purpose;
"recognised laboratory" means any laboratory recognised as such by the Licensing Authority for the purposes of this Act;
"recognised pharmacopeia" means a pharmacopeia recognised by rules for the purpose of this Act;
"responsible pe rson" means any person who is a respon sible person in relation to a wholesale dealer's licence as
provided in article 55(1)(d);
"ri s k - benefit balance" means an ev al uation of th e posit ive therapeutic effects of the medicinal product in relation
to the risks as defined in paragraph (a) of the definition "risks related to use of the medicinal product";
"risks related to use of the medicinal product” means -
(a) any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health;
(b) any risk of undesirable effects on the environment
"rules" means rules made by the Licensing Authority under the provisions of this Act;
"serious adverse rea c tion" me ans an adverse reaction which results in death, is life-threatening, requires inpatient
hospitalisation or prolongation of existing hospitalisation, results in p e rsist e nt o r si gn ifica n t d i sab i l i t y or in
cap acit y, or is a congenital anomaly or birth defect
"st rengt h of the medici nal produ ct " means t he cont ent o f th e active substances expressed quantitatively per dosage
unit, per unit of volume or weight according to the dosage form;
"substance" means any matter irrespective of origin be it human (i nclu din g hum an bl ood an d h u m a n blo od produ
cts), ani m al (including micro-organisms, whole animals, parts of organs, animal
Cap. 31.
Cap. 94.
Cap. 437.
Functions of the Licensing Authority. Amended by:
XI. 2007.3.
secretions, toxins, extracts, blood products), vegetable (including m i cro-o rgani sms, plan ts, part s of plant s, v e getabl e
secretio ns, extracts), or c hemical (including elements, n atu ra ll y occu rr i ng chemical materials and chemical products obtained
by chemical change or synthesis);
"Superintendent of Public Health" has the same meaning as is assigned to it b y article 4 of t h e D e partment of Health (Constitution) Ordinance;
"unexpected adverse reaction" means an adverse reaction, the n at ure, severi ty o r o utcom e of whi ch is n ot co nsistent
with the summary of product characteristics;
"veterinary sur g eon" means a p e rson w ho is au th or ised to exercise such profession under the Veterinary Services Act, or any other law replacing the same;
"w holesale dist rib u ti on", in rel a tio n t o a m e di cinal product , includes all activities consisting of procuring,
holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activi ties are carried
o u t with m anufacturers or their depositori es, importers, other wholesale distributors or with pharmacists and persons authorised
or entitled to supply medicinal products to the public in Malta.
ADMINISTRATION
Title I - The Licensing Authority
Licensing Authority for the purposes of this Act.
(2) The Licensing Authority shall have the following functions: (a) to establish standards to ensure the quality, safety and
efficacy of medicinal products;
(b) to establish standards for the operation of pharmacies; (c) to establish standards for the manufacture, preparation,
assembly, packing, packaging or re-packing and
labelling of medicinal products or any substance which is used or is intended to be used in such products;
(d) to establish standards for the operation of wholesale distribution;
(e) to establish standards for the testing or analysis of medicinal products or any substance which is used or is intended
to be used therein;
(f) to establish standards for the carrying out of clinical trials;
(g) to establish standards for the reporting of adverse reactions, serious adverse reactions or suspected unexpected
adverse reactions and make provision for the collection or submission of related information from any person or activity regulated
by or under this Act;
(h) to establish standards in relation to the advertising of medicinal products;
(i) to advise the Minister in the making of regulations in respect of the classification of medicinal products;
(j) to issue, renew, amend, vary, suspend or revoke marketing authorisations for medicinal products;
(k) to withdraw or recall medicinal products from the market in the interest of public health; and
(l) to ensure compliance with international obligations entered into by the Government of Malta in relation to any matter regulated
by or under this Act;
(m) to issue, renew, amend, vary, suspend or revoke any authorisation or licence that may be required by or under this Act;
(n) to carry out inspections of any activity, service or procedures in relation to medicinal products and to do all such things
as may be necessary for the purpose of ensuring compliance with any provisions of this Act, or made thereunder v;
(o) to authorise the advertising and promotion of medicinal products;
(p) to carry out any other activity as may be prescribed;
(q) to advise the Minister on any matter connected with its functions or any other provision of this Act.
(3) The Licensing Authority may by rules delegate any of its functions referred to in subarticle (2)(l), (m), (n) and (o) to the Medicines Authority.
(4) The Licensing Authority shall levy such fees as may be prescribed for the purpose of this Act:
Provided that such regulations may provide for the waiving of such fees in such circumstances as may be prescribed.
(5) For the proper exercise of its functions, the Licensing Auth ori t y may est a b lish advi so ry co mmitt ees as it
may d e em necessary.
Title II - The Medicines Authority
109A.
Establishment of the Medicines Authority. Substituted by: XXIX. 2007.19.
Legal personality of the Medicines Authority.
(2) The legal and judicial representation of the Medicines
Authority shall vest in the Chief Executive Officer:
Provided that the Medicines Authority may appoint one or more of its officers or employees to appear in its name and on its be hal
f i n an y j u di ci al p r oc eed i ngs or in any act , co ntract , instrument or other document whatsoever.
Functions of the Medicines Authority. Amended by:
III. 2004.45.
(a) to carry out those such functions as may be delegated to it by the Licensing Authority in terms of article
3(3);
(b) to assist and advise the Licensing Authority on any matter relating to the regulation of medicinal products and related activities;
(c) to undertake such activities and projects as may be necessary or expedient for the proper exercise of its functions;
(d) to establish such procedures as may be necessary for obtaining and assessing information as regards the safety, quality
and efficacy of medicinal products to be placed on the market in Malta;
(e) to establish such procedures as may be necessary to make such assessments of medicinal product safety, quality and efficacy
as it may deem necessary for those products to be placed on the market in Malta;
(f) to establish such procedures as may be necessary for monitoring and obtaining reports on the quality, safety or efficacy of medicinal
products;
(g) to make recommendations to the Licensing Authority in relation to standards and licensing;
(h) to advise the Licensing Authority on the precautions or restrictions to which medicinal products may be subjected
for their marketing or continued use in Malta; and
(i) to furnish, whenever it so thinks fit or is so requested by the Licensing Authority, advice or make recommendations
to the Licensing Authority in relation to any matter connected with its functions.
(2) For the proper exercise of its functions, the Medicines Aut hority m a y require the production of such in form ati
on or documents as may be necessary for any of its functions and may seek expert advice from any person, who is not a member of
the Medicines Review Board, possessing the necessary qualifications and experience, and may also establish such advisory committees
as it may deem necessary, either for general or specific purposes.
(3) The Medicines Authority shall levy such fees as may be prescribed for the purposes of this Act:
Provided that such regulations may provide for the waiving
o f s u c h fe es i n s u c h ex ce pt iona l circumstances a s ma y be prescribed.
(2) The Chief Executive Officer shall be responsible for the overall management and performance of the Authority including the
management of the day-to-day operations of the Authority.
(3) A person shall not be eligible to be appointed or to hold office as Director or Chief Executive Officer of the Authority if
he:
(i) is a member of the House of Representatives; or
(ii) is a Judge or a Magistrate; or
(iii) is legally incapacitated; or
(iv) has been declared bankrupt or has made a composition or arrangement with his creditors; or
(v) has been convicted of fraud or any other offence against public trust, or has otherwise been sentenced to a term
of imprisonment for a term not less than three months; or
(vi) has a financial or other interest whether direct or indirect, in any enterprise or activity which is likely to affect the
discharge of his functions as a member of the Authority.
(4) (a) The Chief Executive Officer of the Authority shall hold office for a period not exceeding five years and shall be eligible
for re-appointment for further periods each not exceeding five years.
(b) The Chief Executive Officer of the Authority may be relieved from office by the Minister prior to the expiry of his term of of
fice where, in the opinion of the Minister, he has been guilty of misconduct or on the ground of inability to continue to perform
the functions of his office, whether due to infirmity of mind or of body, or to any other cause, or of misbehaviour.
(2) The Prime Minister may, at the request of the Authority
Organisation of the Medicines Authority.
The Chief Executive Officer of the Medicines Authority.
Employees of the Medicines Authority.
aft e r i t consults with t h e Min i ster, from time to t ime and by direction detail a public officer for duty with the Authority
in such a capacity and for such term and under such conditions as may be established in relation to the officer so detailed.
(3) The Prime Minister may at any time revoke any such direction given under subarticle (2).
(4) Where an officer is detailed for duty with the Authority such officer shall, during the time in which such a direction is
in force, be under the administrative direction and control of the Chief Executive Officer and shall otherwise remain and retain
all rights an d dut ies as a pub lic officer an d for the pur poses o f an y law relating to government service pension, service
with the Authority shall be deemed to be service with the Government:
Provided that no account shall be taken in assessing the pensionable emoluments of such officer for the purposes of any law relating
to government service pensions of any allowances, bonuses or gratuities paid to such officer by the Authority in excess to what he
is entitled as a public officer:
Provided further that during the time in respect of which he is so detailed to perform duties with the Authority the terms and conditions
of his service shall not be less favourable than those whi c h are at tach ed to hi s ap poi ntment un der th e Gov e r n ment during
the period aforesaid. Such terms and conditions shall not be deemed to be less favourable merely because they are not in all respects
identical with or superior to those enjoyed by the officer concerned at the date of such offer, if such terms and conditions, taken
as a whole, in the opinion of the Prime Mini ster o f fer substantially equivalent or greater benefits.
Accounts of the Medicines Authority. Amended by:
XI. 2007.4.
(2) The Authority shall, not later than six weeks after the end of each financial year, present to the Minister and the permanent
secretary the audited accounts to gether with a report on the workings of the Authority which report shall state the manner in which
the Authority has operated to fulfil its functions and its plans in the future.
(3) The reports referred to in subarticle (2) shall be laid on the Table of the House of Representatives by the Minister not later
than six weeks after its receipt, or where the House is during the period no t in sessio n no t later t h an th e secon d week after
th e Hou s e resumes its sittings.
Procurement by the Medicines Authority.
Amended by:
L.N. 427 of 2007.
thousand and nine hundred and thirty-seven euro and thirty-four cents (232,937.34) or such other amount as the Minister may from time to time direct in writing, except after notice of the intention of the Authority to enter into such contract has been published and competitive tenders have been issued.
Title III - Medicines Review Board
(a) a person who shall be a legal practitioner having at least seven years’ legal experience who shall act as the chairperson; and
(b) two other persons who possess the technical and scientific qualifications and experience in the field of regulation of
medicinals.
(2) The Minister shall designate a public officer to act as secretary for the Medicines Review Board.
(3) The members of the Medicines Review Board shall be appointed by the Minister for a te rm o f t h re e ye ars un de
r su ch terms and conditi ons as may b e specified in their appoint ment. Members so appointed may be re-appointed on the expiration
of their term of office.
(4) Where any member of the Medicines Review Board is unable to act, the substitute member having the same qualifications
shall act in his stead.
(5) A person shall not be qualified to hold office as a member or substitute member of the Medicines Review Board if he:
(i) is a member of the House of Representatives, or
(ii) is a Judge or a Magistrate; or
(iii) is legally incapacitated; or
(iv) has been declared bankrupt or has made a composition or arrangement with his creditors; or
(v) has been convicted of fraud or any other offence against public trust, or has otherwise been sentenced to a term
of imprisonment for a term not less than three months; or
(vi) has a financial or other interest, whether direct or indirect, in any enterprise or activity which is likely to affect the
discharge of his functions as a member of the Board.
Applicability of the
Code of Ethics.
Exemption from tax, etc.
Establishment of Medicines Review Board.
Cap. 12.
(6) The provisions of Sub-title II of Title II of Book Third of the Code of Or gani zatio n and Civ il Procedu r e sha l l, mu tat i s mutandis, apply to members of the Medicines Review Board who may be challenged or may abstain from sitting on that Board during the hearing
of an appeal.
(7) A person shall cease to be a member of the Medicines Revi ew Board at the expiration of his term of office, or if
any circumstances arise that, if he were not a member of the Medicines Review Board, he would cease to be qualified for
such appointment.
(8) A member of the Medicines Review Board may be removed from office by the Minister if, in his opinion, such member is no longer
fit to continue in office or has become incapable of properly performing his duties as a member.
Medicines Review Board may appoint advisors.
(2) The Board may also require any government department and, or authority to provide it with such information or advice it may deem necessary for the proper exercise of its functions.
Functions of the Medicines Review Board.
Amended by: XI. 2007.5.
Board:
(a) to hear an appeal submitted by the applicant of a marketing authorisation on any recommendation of the Medicines Authority
in relation to the safety, quality and efficacy of a medicinal product;
(b) to provide advice and make its recommendations to the Licensing Authority regarding any appeal or request made to it.
(2) Concurrently with the submission of its recommendations to the Licensing Authority, the Board shall also submit a copy of such
recommendations to the appellant and to the Medicines Authority.
(3) Any administrative and financial support required by the Medicines Review Board for the performance of its functions shall
be provided by the Licensing Authority.
(4) Subject to the foregoing provisions the business of the Medicines Review Board shall be conducted in accordance with
the rules contained in the Second Schedule and otherwise the Board may regulate its own procedure.
Procedure of appeal.
(2) The Licensing Authority may, if it deems it necessary, within fourteen days of the receipt of the findings
and
recommendations of the Medicines Authority on the safety, quality and efficacy of a medicinal product, request the Medicines Review
Board to provide it with a second opinion on the case.
(3) Any appeal or request for review shall be made in writing and shall be accompanied by the prescribed fee.
(4) The application for an appeal or request for review shall clearly and comprehensively state the grounds for the appeal or review
and shall provide all evidence and documentation to sustain any claim made and which may be necessary to enable the Board to decide
on the case:
Provided that the Medicines Review Board may require the submission of such further information or documentation as it may deem necessary:
Provided further that the Medicines Review Board shall after obtaining all the relevant information, process the application
within a time limit specified in regulations made under this Act.
(2) The Medicines Review Board will inform the appellant, the Licensing Authority and the Medicines Authority of its opinion in writing as soon as is practicable.
GENERAL PROVISIONS
Public hearing.
Applicability of certain provisions. Amended by:
III. 2004.46. Substituted by: XI. 2007.6.
(2) Titles I, II and III of this Act shall not apply to -
(a) any medicinal product prepared in accordance with a magistral formula;
(b) any medicinal product prepared in accordance with an officinal formula;
(c) medicinal products intended for research and development trials, but without prejudice to the provisions
of the Clinical Trials Regulations;
(d) radionuclides in the form of sealed sources;
(e) whole blood, plasma or blood cells of human origin, except for plasma prepared by a method involving an
S.L. 458.43
(f) | industrial process; intermediate products intended for further processing | |
by an authorised manufacturer. | ||
(3) | (a) | The Authority may, in accordance with legislation in force and to fulfil specia l needs, exclude from the provisions of this Act medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility. |
(b) | The Authority may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm: | |
Provided that marketing authorisation holders, manufacturers and health professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal |
Amended by: XI. 2007.7.
Authorisation to place medicinal products on the market.
product otherwise than for the authorised indications
or from the use of an unauthorised medicinal product, when such use is recommended or required by the Authority in response
to the suspected or confirmed
spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. This shall apply irrespective
of whether or not national
or Community authorisation has been granted:
Provided further that liability for defective products, as provided for by Council Directive 85/374/EEC of
25 July, 1985 on the approximation of the laws,
regulations and administrative provisions of the Member States, concerning liability for defective products
shall not be affected by the preceding
proviso.
Title I - Marketing Authorisation Relating to Medicinal Products
Provided that the Licensing Authority may, in exceptional cases, allow the use of a medicinal product without a marketing authorisation
subject to such conditions as it may attach to it:
Provided further that a medicinal product that is essentially
identical to a medicinal product for which a m a rketing authorisa tion has alre ady been gr anted shall only be subject
to conditions as may be determined by the Licensing Authority.
(2) Any application for the grant of a marketing authorisation shall be made to the Licensing Authority and shall be accompanied
by the prescribed fee.
(3) The application shall contain all the information and documents necessary for the assessment of the safety, quality
and efficacy of the medicinal product and shall be submitted in such form and manner as the Licensing Authority may by rules require.
(4) The Licensing Authority shall forward the application submitted to it to the Medicines Authority as soon as possible.
(5) Where an application for the issue of a marketing authorisation is received by the Medicines Authority, the
Authority may -
(a) refuse to process the application if such application is not submitted in accordance with the provisions of this Act;
(b) request the applicant to furnish it with such further information relating to the application as it may consider necessary;
and where any such request has been made, the Medicines Authority shall not be required to determine the application
until the information as requested has been submitted to it;
(c) assess the application in respect of medicinal product safety, quality and efficacy in such a manner and within such
period as may be prescribed by or under this Act; and
(d) carry out any other activity as may be prescribed by the Minister from time to time.
(6) The Medicines Authority shall report its findings and make its recommendations to the Licensing Authority, and shall submit
a copy thereof to the applicant, in such a manner and within such period as may be prescribed.
(2) The decision of the Licensing Authority shall be final and toge ther with the detaile d reas ons for such decision shall be communica ted to the M e dicines Review Board, the Me dicines Authority and the applicant as necessary.
Review or appeal.
Granting of marketing authorisation.
(2) A marketing authorisation shall specify:
(a) the summary of product characteristics as approved;
Notification of marketing authorisation.
(b) the approved labelling and packaging;
(c) any conditions that may be attached to the granting of the marketing authorisation;
(d) the classification of the medicinal product;
(e) the term of validity of the marketing authorisation;
(f) any other specification that the Licensing Authority may deem necessary.
Validity of market authorisation.
(2) Every marketing authorisation so granted under this Act shall unless previously revoked, be renewable upon an application by the holder made at least three months before the expiry of the period of validity.
Application of renewal.
(2) Notwithstanding the provisions of any other law, no court m a y issue a warrant of prohibitory injunction restrainin g the Licensing Authority from determining any such application.
Notification of refusal.
Refusal to renew marketing authorisation.
26. The Licensing Authority shall refer an application for renewal of a marketing authorisation to the Medicines Authority, and in such case the provisions of article 20(4), (5) and (6) and of article 21 shall, mutatis mutandis apply.
Provided that the Licensing Authority shall notify the M e di ci ne s A u t h o r it y an d t h e ap pl ic ant of t h e d eci
si on g i v i ng detailed reasons for such decision.
(2) A renewal of a marketing authorisation shall specify -
(a) the summary of product characteristics as approved; (b) the approved labelling and packaging;
(c) any conditions that may be attached to the granting of the marketing authorisation;
(d) the classification of the medicinal product;
(e) the term of validity of the marketing authorisation;
(f) any other specification that the Licensing Authority may deem necessary.
(a) the medicinal product is harmful under normal conditions of use; or
(b) it lacks therapeutic efficacy, where such lack of therapeutic efficacy shall be deemed as occurring when it is concluded
that therapeutic results cannot be obtained from the medicinal product; or
(c) the risk benefit balance is not favourable under the authorised conditions of use; or
(d) its qualitative and quantitative composition is not as declared; or
(e) the controls on the medicinal product and, or on the ingredients and the controls at an intermediate stage of the manufacturing
process have not been carried out, or if the requirement or obligation relating to the grant of the manufacturing authorisation
has not been fulfilled:
Provided that the Licensing Authority may limit the prohibition to supply the medicinal product, or its withdrawal from
the market, to those batches which are the subject of dispute.
(2) An authorisation shall also be suspended, revoked, wit hdrawn or varied wh ere the part icul ars su ppo rt ing
th e application as provided for in this Act are found to be incorrect or have been amended without authorisation or when the requisite
controls required by or under this Act have not been carried out.
(3) When the packaging, labelling or the package leaflet of the medicinal product in question do not comply with the requirements
as sp eci fied by or under th is Act, t he Licensin g Au thority may suspend the marketing authorisation by notice served on the
holder of the marketing authorisation concerned and the suspension shall continue to have effect until the Licensing Authority is
satisfied that the requirements have been fulfilled.
(4) If the Licensing Authority suspends or revokes a marketing author isatio n, it shal l not ify the hold e r of the mar
k eting authorisation and the Medicines Authority of such decision stating
in detail the reasons on which such a decision is based.
(5) The holder of the marketing authorisation may, within fourteen days of such notification, request the Medicines Review
Board to examine the circumstances leading to the suspension or the revocation of the marketing authorisation, and the Medicines
Review Board shall make its recommendations on the matter to the Licensing Authority:
Provided that the request shall not suspend the effects of the decision of th e Licensing Aut hority and that the Licensi n g Authority
shall not be bound by the recommendations made by the Medical Review Board.
Suspension or revocation of marketing authorisation. Amended by: XI. 2007.8.
(6) The Licensing Authority shall suspend or revoke the marketing authorization for a cate gory of preparations or all preparations
where the provisions of Title II are not complied with.
(7) The provisions of this article and of articles 99 to 104, shall apply to homeopathic medicinal products.
Classification of medicinal products.
(a) a medicinal product subject to a medicinal prescription; or
(b) a medicinal product not subject to a medicinal prescription, where such medicinal product is considered
that with reasonable safety it can be sold or supplied by or under the supervision of a pharmacist unless otherwise provided
for by this Act that a medicinal product under subarticle (1)(b) is classified under subarticle (1)(a).
(2) The Licensing Authority may by rules determine the type, content and presentation or otherwise of a prescription and who is
authorised to issue the said prescription that may be needed for a medicinal product or class of medicinal products.
List of medicinal products having a marketing authorisation.
(a) the medicinal products that have a valid marketing authorisation;
(b) the medicinal products which may only be sold by prescription; and
(c) where applicable, the type of prescription required and the person or persons authorised to issue the said prescription.
(2) Whenever a marketing authorisation has been issued in relatio n to a medi cin a l pr odu ct th e Li censi ng Aut hori
t y shall publish in the Gazette the information specified in subarticle (1)(a), (b) and (c) and such publication shall be deemed to amend the list of medicinal products issued under subarticle (1).
(3) The Licensing Authority shall publish in the Gazette, as soon as is practical, the list of medicinal products for which the
marketing authorisation has been suspended or revoked and such publication shall be deemed to amend the list of medicinal products
issued under subarticle (1).
Advertising of medicinal products.
32. (1) Without prejudice to article 28, homeopathic medicinal products which satisfy the conditions in paragraphs (a) to (c) shall be subject to special simplified procedures as provided in subarticle (2) to (4). The pro d u cts to whi c h th is sub a
rti c le applies are products which -
(a) are administered orally and externally, subject to such regulations as may be made by the Minister in respect thereof;
(b) have no specific therapeutic indication appearing on the labelling of the medicinal product or in any information relating
thereto; and
(c) have a sufficient degree of dilution to guarantee the safety of the medicinal product, in particular, the medicinal product
may not contain either more than one part per 10,000 of the mother tincture or more than
1/100th of the smallest dose used in allopathy with regard to active principles whose presence in an allopathic medicinal product
results in the obligation to submit a medicinal prescription.
(2) The criteria and rules applicable to the granting of a marketing authorization shall also apply to the special simplified
procedure with the exception of the proof of therapeutic efficacy.
(3) Any application for the registration of a homeopathic medicinal product shall contain such documents and information
as may be prescribed by regulations made under this Act and such application may cover a series of medicinal products derived from
the same homeopathic stock or stocks.
(4) Homeopathic medicinal products which do not satisfy the cond itions prescribed in subarti cle (1 ) shall be autho r ized and
labelled in accordance with the provisions of this Act applicable to medicinal products, and shall also be subject to the requirements
of pharmacovigilance as established by regulations under this Act.
(5) The Minister may by regulations under this Act prescribe rules for the toxicological and pharmacological tests and clinical
trials of homeophathic medicinal products.
Homeopathic medicinal products. Amended by: III. 2004.47; XI. 2007.9.
industrially prepared radi opharm aceuticals other than radiopharmaceuticals prepared at the time of use by a person or by
an establishment authorised, under this Act, to use such medicinal products in an approved health care establishment exclusively from
authorised generators, kits or precursor radiopharmaceuticals in
accordance with the manufacturer ’s instructions.
Products derived from human blood or human plasma.
Radio- pharmaceutical medicinal product.
Immunological medicinal products.
(2) The Licensing Authority may prescribe rules regulating the issue or otherwise of a marketing authorisation for immunological medicinal products.
Herbal medicinal products. Amended by:
III. 2004.48.
Manufacturer’s licence.
Title II - Manufacture of Medicinal Products for Human Use
Provided that such a licence shall not be required for the preparation, division, changes in packaging or presentation where these processes are carried out for the purpose of dispensing or administering as provided under this Act.
Application for manufacturer’s licence.
Provided that such application shall indicate the following: (a) the name of the medicinal product and pharmaceutical
form or forms, which is to be manufactured, assembled or in any way modified;
(b) the place where such activity is to take place, and such information and documentation as may be required in order to show that
such place is suitable and sufficient for that purpose;
(c) the equipment and control facilities as may be required by or under this Act;
(d) the name and address of the applicant;
(e) the name of at least one qualified person who shall be professionally responsible for the activity, such person having such qualifications
as may be prescribed:
Provided that when more than one qualified person is nominated, the application will clearly delineate the specific responsibilities
of each person;
(f) any other information, documentation or evidence as may be requested by the Licensing Authority in accordance with or
under this Act.
(2) The Licensing Authority shall determine the application in the period of time as may be established under this Act:
Provided that such time may be suspended until the relevant
information is provided.
Provided that a licence may be made conditional to the carrying out of such obligations as may be imposed therein.
(2) The manufacturer's licence shall specify the premises and the medicinal products and pharmaceutical form or forms to which
it applies.
(3) The licence holder shall ensure that the activity is carried out in accordance to the provisions of this Act and any regulations
made thereunder.
Granting of manufacturer’s licence.
(2) The powers vested in subarticle (1) shall only be exercisable in any of the following circumstances, where:
(a) the matters stated in the application on which the licence was granted were false or incomplete in a material
particular;
(b) a material change of circumstances has occurred in relation to any of those matters;
(c) any of the conditions of the licence has been contravened;
(d) the requirements in relation to the licences as established by or under this Act have not been complied
with;
(e) the processes of manufacture or assembly of a medicinal product are carried out in a manner that is not in compliance
with the provisions of the marketing authorisation of that medicinal product;
(f) the conditions for good manufacturing practice are not being complied with; and
(g) in any other circumstance as is established by or under this Act.
Notice for further information.
Suspension or revocation of manufacturer’s licence. Amended by: XI. 2007.10.
Inspection in relation to manufacturers, etc.
a medicinal product are complied with.
(2) The Licensing Authority or any person carrying out an inspection shall:
(a) inspect the manufacturing establishment and any other location he may deem necessary;
(b) examine any relevant documents;
(c) take any samples he may deem necessary;
(d) draw up a report of the findings and communicate the contents of such report to the licensee or the applicant for a licence in
relation to such inspection and to the qualified person;
(e) carry out any other activity he may deem appropriate for the proper execution of his duties and responsibilities
as provided for by or under this Act.
(3) Except in urgent cases an inspection shall be carried out in the presence of a qualified person or his representative, if any.
Duration and renewal of manufacturer's licence.
(2) Any licence so granted shall, unless previously revoked, be renewable upon an application by the licensee made at least three
months before the expiry of the validity period.
(3) The Licensing Authority may by rules establish the period of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the renewal of a licence under this Part, the Licensing Authority:
(a) may renew the licence, with or without modifications, for such a further period as specified; or
(b) if, having regard to the provisions of this Act, it considers it necessary or expedient to do so, may refuse
to renew the licence.
(5) The provisions of articles 25, 39 and 40 shall apply to such applications.
Responsibilities of manufacturer’s licence holder.
(a) to immediately inform the Licensing Authority of any change of the qualified person;
(b) to provide authorised officers access to his premises at any reasonable time;
(c) to enable the qualified person to carry out his duties established by or under this Act;
(d) to maintain such records for any transaction in medicinal products as may be established by or under this Act and
have such records available for inspection by any authorised officer for such period of time as
may be required by or under this Act;
(e) to have at his disposal the services of staff to satisfy the requirements specified by or under this Act in relation
to the manufacture, assembly or modification of medicinal products;
(f) to apply in writing to the Licensing Authority of any change proposed or modification required in relation to the licence;
(g) to comply with the regulations or Orders relating to good practice in manufacture as may be established by or under this Act
or under any other Act;
(h) to dispose of medicinal products as established by or under this Act or under any other Act;
(i) other responsibilities as may be established from time to time by or under this Act.
(a) to ensure that standards of good practice in manufacturing are complied with at all times;
(b) to ensure that each batch of medicinal products has been manufactured, tested and complies in all respects with any requirement
established by or under this Act; and
(c) to ensure that each batch of medicinal products has been manufactured in accordance with the requirements
of the marketing authorisation.
(2) The qualified person shall be permanently and continuously at the disposal of the holder of the manufacturer ’s licence:
Provided that the qualified persons may nominate another person similarly qualified to act as his representative.
(3) When the qualified person has nominated a representative as aforesaid he shall immediately inform the Licensing Authority of
such nomination.
Responsibilities of the qualified person.
Amended by: III. 2004.49.
Suspension of activity of a qualified person.
Change in conditions of manufacturer’s licence.
Obligations of Licensing Authority.
Manufacture of homeopathic medicinal products. Substituted by: XI. 2007.11.
Manufacture of medicinal products derived from human blood and human plasma, etc. Amended by:
XI. 2007.12.
Manufacture of radio- pharmaceuticals. Amended by:
XI. 2007.12.
Immunological medicinal product. Amended by:
XI. 2007.12.
Herbal medicinal products. Amended by:
XI. 2007.12.
apply.
37 to 48 and any regulations made thereunder shall apply to the manu facture and assembly of medicinal products derive d from
human blood and human plasma.
37 to 48 and any regulations made thereunder shall apply to the m a nu fac t ure an d assemb ly of radi oph armaceu ti cal med
i ci nal
products.
37 to 48 and any regulations made thereunder shall apply to the manufacture and assembly of immunological medicinal products.
37 to 48 and any regulations made thereunder shall apply to the manufacture and assembly of herbal medicinal products.
Title III - Wholesale Distribution of Medicinal Products for Human Use
Wholesale dealing. 54. (1) Without prejudice to any exemptions that may be g r anted by or u nder thi s Act, no person sh all en gage in the wholesale distribution of any medicinal product unless he is the holder of a wholesale dealer's licence issued in accordance with the provisions of this Act. and unless the medicinal product has been granted a marketing authorisation by the Licensing Authority.
(2) The wholesale distribution of a medicinal product by way of wholesale dea l ing shall only be car r ied o u t fr om th e pl ace specified in, and in accordance with the conditions of, the licence.
Application for a wholesale dealer’s licence.
Provided that such application shall indicate the following: (a) the name and address of the applicant;
(b) the address of the premises that are to be used for the
purpose of wholesale distribution;
(c) the equipment and control facilities as may be required by or under this Act;
(d) information, documentation or evidence to prove that the premises is suitable and adequate, and that there are suitable facilities,
installations and equipment so as to ensure proper conservation and distribution of medicinal products;
(e) the name of at least one responsible or qualified person who shall be professionally responsible for the activity,
such person having such qualifications as may be prescribed:
Provided that when more than one qualified or responsible person is nominated, the application will clearly delineate the specific
responsibilities of each person;
(f) any other information, documentation or evidence as may be requested by the Licensing Authority in accordance with or
under this Act.
(2) The Licensing Authority shall determine the application in the period of time as may be established under this Act:
Provided that such time may be suspended until the relevant information is provided.
Provided that a licence may be made conditional to the carrying out of such obligations as may be imposed therein.
(2) The wholesale dealer ’s licence shall specify the premises and the activities to which it applies.
(3) The licence holder shall ensure that the activity is carried out in accordance to the provisions of this Act and any regulations
made thereunder.
Granting of a wholesale dealer’s licence.
(2) Any licence so granted shall, unless previously revoked, be renewable upon an application by the licensee made at least three
months before the expiry of the validity period.
(3) The Licensing Authority may by rules establish the period of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the renewal of a licence under this Part, the Licensing Authority:
(a) may renew the licence, with or without modifications, for such a further period as specified; or
(b) if, having regard to the provisions of this Act, it
Notice for further information.
Duration and renewal of wholesale dealer’s licence.
considers it necessary or expedient to do so, may refuse to renew the licence.
(5) The provisions of articles 25, 39 and 40 shall apply to such applications.
Obligations of holder of wholesale dealer’s licence.
(a) to immediately inform the Licensing Authority of any change of the qualified or responsible person;
(b) to provide authorised officers access to his premises at any reasonable time;
(c) to enable the Licensing Authority to carry out its duties established by or under this Act;
(d) to maintain such records for any transaction in medicinal products as may be established by or under this Act and
have such records available for inspection by any authorised officer for such period of time as may be required by or under this
Act.
Responsibilities of the responsible person.
Amended by: III. 2004.50.
(2) The qualified person or responsible person shall be permanently and continuously at the disposal of the holder
of the wholesale dealer ’s licence:
Provided that the qualified or responsible person may nominate another person to act as his representative.
(3) When the qualified or responsible person has nominated a representative as afo r esaid h e shall immediately inform th e
Licensing Authority of such nomination.
Suspension or revocation of wholesale dealer’s licence.
(a) where the matters stated in the application on which the licence was issued were false or incomplete in a material particular;
(b) where a material change of circumstances has occurred in relation to any of those matters;
(c) where any of the conditions of the licence has been contravened;
(d) where the requirements in relation to the licence as established by or under this Act have not been complied with;
(e) where conditions of good practice in wholesale distribution are not being complied with; and
(f) in any other circumstance as may be established by or
under this Act.
63. The Licensing Authority may vary, suspend, revoke or refuse to renew a wholesale dealer ’s licence, or it may refer the matter to the Medicines Authority, and in such case the provisions of article 20(4), (5) and (6) and of article 21 shall, mutatis mutandis apply.
(2) The Licensing Authority shall:
(a) inspect the wholesale dealing establishment and any other location it may deem necessary;
(b) examine any documents relating to the inspection; (c) take any samples it may deem necessary;
(d) draw up a report of the findings, which shall be communicated to the licensee or the applicant for a licence in relation
to such inspection and to the responsible person;
(e) carry out any other activity it may deem appropriate for the proper execution of its duties and responsibilities
as provided for by or under this Act.
Change in conditions of a wholesale dealer’s licence.
Obligations of Licensing Authority.
Inspecting in relation to wholesale.
(a) narcotic or psychotropic substances;
(b) medicinal products derived from blood; (c) immunological medicinal products;
(d) radiopharmaceuticals;
(e) such other medicinal products or class or classes of medicinal products as the Minister may prescribe.
Title IV - Pharmacies and Related Pharmaceutical Activity
(2) Licences are to be issued in accordance with geo- demographic criteria as may be established by regulations
made under this Act.
(3) Regulations under this article shall not be made unless the
Minister shall have first publ ish e d a dr af t th ere o f i n th e
Special provisions.
Licence to open a pharmacy.
Government Gazette allowing any person a period of at least four weeks to make representations to the Minister.
(4) The Minister shall request the Licensing Authority to report on any representation made to him after hearing such person or
taking such expert advice as it considers expedient, together with any views it may have and the Minister may, upon receipt of the
repo rt by t h e Licensing Auth ority p r oceed to revise th e draft regulations and to promulgate such regulations in accordance
with such revision.
(5) Without prejudice to any exemption that may be granted by or un der t h i s Act, no perso n shall sel l by retail any medi
ci nal product expect in accordance with a pharmacy licence issued in accordance with the provisions of this Act or any regulations
or rules made thereunder.
(6) The licensee shall be responsible for complying with the conditions of the licence as may be established by or under this Act.
Application for a pharmacy licence.
Provided that such application shall indicate the following: (a) the name and address of the applicant;
(b) the address of the premises that are to be used for the
purpose of the retail sale of the medicinal products;
(c) the equipment and control facilities as may be required by or under this Act;
(d) information, documentation or evidence to prove that the premises is suitable and adequate, and that there are suitable facilities,
installations, and equipment so as to ensure proper conservation and dispensing of medicinal products;
(e) the name of a managing pharmacist who shall be professionally responsible for all activities;
(f) any other information, documentation or evidence as may be requested by the Licensing Authority in accordance with or
under this Act.
(2) The Licensing Authority shall determine the application in the period of time as may be established under this Act:
Provided that such time may be suspended until the relevant information is provided.
Grant of a pharmacy licence.
Provided that a licence may be made conditional to the
carrying out of such obligations as may be imposed therein.
(2) The pharmacy licence shall specify the premises and the activities to which it applies:
Provided that the Licensing Authority may, upon application, grant an additional licence for the use of identified
premises to be used as a store for the purpose of the pharmacy after it is satisfied that such premises comply with any requirements
established by or under this Act.
(2) Any licence so granted shall, unless previously revoked, be renewable upon an application by the licensee made at least three
months before the expiry of the validity period.
(3) The Licensing Authority may by rules establish the period of validity of any licence issued under this Part.
(4) On an application to the Licensing Authority for the renewal of a licence under this Part, the Licensing Authority:
(a) shall renew the licence, with or without modifications, for such a further period as specified; or
(b) if, having regard to the provisions of this Act, it considers it necessary or expedient to do so, may refuse
to renew the licence.
(5) The provisions of articles 25 and 39 shall apply to such applications.
Notice for further information.
Duration and renewal of pharmacy licence.
(a) where any matter stated in the application on which the licence was issued is false or incomplete
(b) where a material change of circumstances has occurred in relation to any of those matters;
(c) where the provisions of the licence have been
Transfer of a pharmacy licence.
Suspension or revocation of pharmacy licence.
contravened by the licensee; or
(d) in any other circumstance as may be established by or under this Act:
Provided that the Licensing Authority shall notify the licensee of the decision giving detailed reasons for such decision.
Temporary closure of pharmacy.
Provided that the temporary closure shall not be construed to include the closure of a pharmacy resulting from the unforeseen or unexpected
absence of a pharmacist, force majeure resulting in the inability to open the premises, or closure outside the business hou rs establ ished for ph arm a cies b y r u les
made t h e Li censi n g Authority.
(2) Subject to the provisions of subarticle (1), the licence in relation to a pharmacy which has remained closed for a period of
f ive con secu tiv e wo rk ing day s wi tho ut the auth or isatio n of the Licensing Authority shall be deemed to have been automatically
revoked.
(3) The Licensing Authority may, on receipt of a notice as is referred to in subarticle (1), or where it has come to its knowledge
that a pharmacy has been closed, seal all the medicinal products, wherever kept by the licensee in terms of the provisions of this
Act, and take charge of any register required to be kept by the licensee under this or any other law.
Obligations of the holder of a pharmacy licence.
(a) to inform the Licensing Authority of any change of the managing pharmacist, prior to such change;
(b) to provide authorised officers access to his premises at any reasonable time;
(c) to enable the Licensing Authority to carry out its duties established by or under this Act;
(d) to maintain such records for any transaction in medicinal products as may be established by or under this Act and
have such records available for inspection by any authorised officer for such period of time as may be required by or under this
Act;
(e) to comply with regulations or Orders relating to good practice in retail sale of medicinal products as may be established by or
under this Act;
(f) to dispose of medicinal products as established by or under this Act or any other law;
(g) other responsibilities as may be established from time to time by or under this Act.
Managing pharmacist.
hereinafter referred to as the "managing pharmacist". (2) The managing pharmacist shall:
(a) act as the managing pharmacist of a licensed pharmacy including any other premises used as a store by the said pharmacy in terms
of article 68(2);
(b) ensure that he or another pharmacist sells or supervises the sale of medicinal products present in the pharmacy and keep records
of the pharmacist who was present at all times while the pharmacy was open;
(c) keep any documents, information or evidence in the manner as may be required to be kept by or under this Act;
(d) carry out such obligations pertaining to a managing pharmacist as may be established by or under this Act;
(e) nominate a substitute managing pharmacist when he cannot carry out his duties for a period of five or more consecutive days
and shall notify the Licensing Authority of this substitution:
Provided that in exceptional cases the licensee may nominate a replacement and notify the Licensing Authority;
(f) comply with regulations or rules relating to good practice in the dispensing of medicinal products as may be established
by or under this Act;
(g) dispose of medicinal products as established by or under this Act or any other law.
(3) No pharmacist may, without the authority in writing of the Licensing Authority, act as a managing pharmacist of two or more
pharmacies:
Provided that the Licensing Authority shall not give such authority unless it is satisfied that such pharmacist can reasonably carry
out the duties of a managing pharmacist for more than one pharmacy.
(4) No pharmacist shall take up or abandon his duties as a managing pharmacist of any pharmacy without giving prior notice
in writing to that effect to the Licensing Authority.
Provided that a pharmacist may permit medicinal products to be prepared or dispensed by a pharmacy technician under his personal
supervision as regulated by or under this Act.
(2) In carrying out his functions in the preparation and dispensing of medicinal products from a pharmacy, a pharmacist
shall act in accordance with such standards as may be established by or under this Act or any other Act.
Duties of pharmacist.
pharmacy. Substituted by: XI. 2007.13.
Licensee may employ one or more pharmacists.
Medicinal products to be sold from a pharmacy.
no t have a di rect or in di rect in terest in a ph ar macy sh all b e prescribed under this Act.
(2) Unless otherwise provided by or under this Act, a medicinal product shall only be sold from a pharmacy:
Provided that the Licensing Authority may, in special circumstances relating to the provision of services to the public, by
rules p r escribe that a m e dicina l product or class or classes of medicinal products therein specified may be sold from a premises
ot her t han a pharmacy such p remi ses not being a general retail outlet:
Provided further that the Licensing Authority may with same circumstances by rules prescribe that a medicinal product of class
or classes of medicinal products therein specified may be sold, prepared or provided to a patient by a person, other than a pharmacist,
who is suitably qualified for such purpose:
Provided also that such rules shall provide for the circumstances under which such a sale, preparation or provision
may occur and impose such restrictions as may be provided.
(3) The Licensing Authority may by rules establish a list of m e dicin a l products that as a minimum must be available at a pharmacy
at all times:
Provided that this requirement may be temporarily waived in relation to a particular medicinal product or class of medicinal product
in exceptional circumstances, if the Licensing Authority is satisfied that the unavailability of such a medicinal product or class
of medicinal product from a pharmacy is beyond the control of the managing pharmacist.
Dispensing of a medicinal product. Amended by:
XI. 2007.14.
(2) Upon presentation of a prescription for a medicinal product, unless the prescriber specific ally requests a part ic ular br
anded product by writin g "b rand ed" or "®" on the prescription , a pharmacist can dispense the medicinal
product prescribed or an equivalent medicinal pr oduct having the s ame chemic al entity, dose, dosage form and dosage frequency
as the medicinal product
indicated on the prescription.
(3) When, in dispensing any medicinal product, a pharmacist discovers that there are reasons why the medicinal product should not
be dispensed to the patient or that the dosage regimen indicated on the prescription goes beyond what can be considered a safe therapeutic
dose, the pharm acist is bound to draw the attention thereto of the person prescribing the same and may require such person to write
ou t in i nk or in ot her ind e l i ble mann er on t h e prescripti on a statem en t assum i ng resp onsibili ty for t h e
prescription.
(4) The pharmacist shall assume full responsibility for the dispensing of medicinal products which do not need a prescription
for dispensing to patients.
(2) The provisions of subarticle (1) shall also apply to products or substances not classified as medicinal products but which have been deemed to require a medicinal prescription for their use by the relevant competent authority.
Dispensing against prescription.
(a) any imperfect, deteriorated or harmful substance;
(b) any medicinal product bearing an expiry date which has expired;
(c) food not in accordance with the provisions of the Food
Safety Act, or any regulations made thereunder:
Provided that such imperfect, deteriorated or expired substances or medicinal products shall only be kept in such place
and in such a manner as the Licensing Authority may from time to time by rules establish.
Presentation of a prescription.
Labelling of dispensed products. Amended by: XI. 2007.15.
Disposal of expired, deteriorated or imperfect products.
Cap. 449.
(2) It shall not be lawful for any managing pharmacist to permit
Storage of medicinal products in pharmacy.
the pharmacy under his management, and it shall be his duty to ensure that the pharmacy has the facilities to ensure that medicinal
products are stored in accordance with storage recommendations:
Provided that in the case where the Licensing Authority has granted a licence for the keeping or storage of medicinal products in
any premises other than the pharmacy, the responsibilities of the managing pharmacist shall also apply to such premises.
Premises, etc., in accordance with requirements and standards.
Pharmacist to be guided by set standards. Amended by:
XI. 2007.16.
Inspections of pharmacies.
(2) Any inspection as aforesaid shall be carried out in the presence of the managing pharmacist or of the pharmacist for
the time being in charge of the pharmacy.
(3) At the time of the inspection, the inspecting officer shall draw up a list of deficiencies that may have been identified at
the time of the inspection and shall sign this list, and such list shall be countersigned by the managing pharmacist or by the pharmacist
for the time being in charge of the pharmacy:
Provided that the inspecting officer shall draw up a report of the inspection within seven working days of the inspection and shall
forward a copy of such report to the Licensing Authority, the licensee and the managing pharmacist:
Provided also that the managing pharmacist or pharmacist for the time being in charge of the pharmacy may make comments or otherwise
make reservations in respect of the contents of the said list.
(4) (a) If in the course of the inspection, any article is found to be in breach of the prov isions of this Act or any regulation made
thereunder, the inspecting officer shall forthwith seize the said article.
(b) The wrapper or receptacle containing the article so sei z ed shall be sealed and the signature of the inspecting officer
and the managing pharmacist shall be appended to the seal:
Provided that if the managing pharmacist so requests, the article in question shall be divided, by the inspecting officer, in
two equal parts, sealed and signed
in the manner as aforesaid, and one part be given to the managing pharmacist:
Provided further that the inspecting officer shall send the seized article, sealed and signed in the manner aforesaid to the Licensing
Authority together with the inspection report as described in subarticle (3).
(5) If the managing pharmacist or the pharmacist for the time being in charge of the pharmacy r efu ses to cou nte rsig n t he
list referred to in subarticle (3), the inspecting officer shall record such fact on the said list together with the reason given,
if any, for such refusal.
Opening of pharmacies.
POISONOUS SUBSTANCES
(a) all those substances which, taken even in a very small dose, may cause the death or serious injury to any person,
(b) all those substances which the Minister may, on the advice of the Licensing Authority, prescribe,
but does no t in cl ude an y sim ilar su bstance wh ich i s used, or is intended to be used, for day to day domestic purposes, which
latter substance, however shall be deemed to be a poison for the purpose of article 94.
(2) Such licence shall show the name and surname of the licensee, his trade or profession, and the place in which he intends to carry on such trade or profession and any other information as m a y b e estab lish e d fro m t ime to t ime b y ru les mad e by t h e Licensing Authority.
Definition of poisons.
Keeping, etc., of poisons.
Licence for sale of poisons.
Keeping of poisonous substances in a safe place.
Sale of poisonous substances.
prescription or for purposes of disinfection or industry or for any other purpose as may be authorised by the Licensing Authority.
(2) Every person granted a licence under article 91 shall keep, m a in tai n , up dat e , store an d m a ke available to the Licensing
Authority or any authorised person any information as may from time to time be required by the Licensing Authority and in any such
manner as may be form time to time be required by the Licensing Authority.
(3) Poisonous substances shall be labelled in such a manner the
Licensing Authority may from time to time by rules establish.
Power of inspection.
Poisoned grain, seed etc.,
Cap. 430.
Special restrictions on persons to be supplied with medicinal
products.
Adulteration of medicinal products.
OTHER DEALINGS WITH MEDICINAL PRODUCTS
(a) being the holder of a marketing authorisation, or
(b) in the course of business carried by him and consisting, in whole or in part, of manufacturing medicinal
products or of selling medicinal products by way of wholesale dealing,
shall sell or supply any medicinal product to which the rules apply to any person who does not fall within a class specified in those
rules.
(a) add any substance to, or abstract any substance from, a medicinal product so as to affect injuriously the composition
of the product, with the intent that the product shall be sold or supplied in that state; or
(b) sell or supply, or offer or expose for sale or supply, or have in his possession for the purpose of sale or supply,
any medicinal product whose composition has been injuriously affected by the addition or abstraction of any substance.
OFFENCES AND PENALTIES
(a) the provisions of articles 20, 24, 28, 37, 39, 41 and 43, to a fine (multa) of not less than twenty-three thousand and two hundred and ninety-three euro and seventy- three cents (23,293.73) and not exceeding
one hundred and sixteen thousand and four hundred and sixty-eight euro and sixty-seven cents (116,468.67) or to imprisonment
for a term not exceeding two years, or both such fine and imprisonment;
(b) the provisions of articles 54, 56, 58 and 61, to a fine (multa) of not less than eleven thousand and six hundred and forty-six euro and eighty-seven cents (11,646.87) and not exceeding
sixty-nine thousand and eight hundred and eighty-one euro and twenty cents (69,881.20) or to imprisonment for a term
not exceeding six months, or both such fine and imprisonment;
(c) the provisions of articles 44, 45, 66(1), 71, 75(3),
75(4), 76(1), 81(1), 91 and 98, to a fine (multa) of not less than four thousand and six hundred and fifty-eight euro and seventy-five cents (4,658.75) and not
exceeding forty-six thousand and five hundred and eighty-seven euro and forty-seven cents (46,587.47) or to imprisonment
for a term not exceeding three
months, or to both such fine and imprisonment;
(d) the provisions of articles 59, 60, 65, 74(b), 75(1),
75(2), 84, 93, 94(1) and 96, to a fine (multa) of not less than one thousand and one hundred and sixty-four
euro and sixty-nine cents (1,164.69) and not exceeding twenty-three thousand and two hundred and ninety- three euro and seventy-three
cents (23,293.73);
(e) the provisions of articles 31, 78, 85(1), 85(2) and
94(2), to a fine (multa) of not less than four hundred and sixty-five euro and eighty-seven cents (465.87)
and not exceeding eleven thousand and six hundred and forty-six euro and eighty-seven cents (11,646.87);
(f) the provisions of articles 29, 73(1) and 94(3), to a fine (multa) of not less than two hundred and thirty-two euro and ninety-four cents (232.94) and not exceeding two thousand and three hundred
and twenty-nine euro and thirty-seven cents (2,329.37).
(2) Without prejudice to the powers of the Licensing Authority under this Act, where any person who has committed an offence is
the holder of a licence or an authorisation under this Act, and the
Offences and penalties. Amended by: XI. 2007.17;
L.N. 427 of 2007.
the request of the prosecution, order the revocation or suspension of the aforesaid licence or authorisation.
Special procedure.
Amended by:
L.N. 427 of 2007.
Cap. 9.
Right of entry. Amended by: XI. 2007.18.
(2) The Minister shall prescribe the penalties that may be demanded by the Licensing Authority in relation to any specified
offence:
Provided that such penalty shall not exceed an amount of twenty-three thousand and two hundred and ninety-three euro and seventy-three
cents (23,293.73).
(3) Where a notice under this article has been given, the person named in the notice may, within twenty-one days of the service
of the notice, accept responsibility for the offence specified in the notice and within the same period pay the penalty indicated
in the notice, and comply with the relative provision of this Act, or of the regulations or rules made thereunder and no further
proceedings may be taken under this Act in respect of such offence.
(4) Where the person to whom notice is given under subarticle (1) has not p a id the penalty w ithin the twenty-one day period
referred to in subarticle (3) and has not, within the time specified, complied with the requirements of this Act, criminal proceedings
may be taken against him in accordance with the provisions of the Criminal Code, of this Act and of any other law applicable of the
offence.
ENFORCEMENT
(a) for the purpose of ascertaining whether there is or has been, or there is likely to be any contravention of any provisions of
this Act or of any regulations or rules made thereunder;
(b) generally for the purposes of the exercise by the Licensing Authority of its function under this Act or under any regulations
or rules made thereunder.
For the purposes of this Part, premises shall include any building, structure, any other place whatsoever or any means of transport.
(2) Any authorised officer shall, on the production of his authorisation, have a right at any reasonable time to board
any ship or aircraft for the purpose of ascertaining whether there is in the ship or aircraft any substance or article imported in
contravention of any provisions of this Act or of any regulations or rules made thereunder or whether the said craft is carrying
out any activity in contravention to any of the said provisions.
(a) any substance or article appearing to him to be a medicinal product;
(b) any article used or intended to be used to contain any medicinal product or to be a label or leaflet used or intended to be
used in connection with a medicinal product; or
(c) any plant or equipment appearing to him to be used or intended to be used in connection with the manufacture
or assembly of medicinal products, and any process of manufacture or assembly of any medicinal products and the means
employed, at any stage in the process of manufacture or assembly, for testing the materials after they have been subjected to those
processes:
Provided that an authorized officer may also carry out i n spect i on s of st ar ting material manufac t urers after a specific
request for the purpose is made by such manufacturer himself:
Provided further that the samples that may be collected may be analysed at a designated laboratory identified by the Authority.
(2) An authorised officer may, for the purpose specified in the preceding subarticle, take a sample of any:
(a) substance or medicinal product sold or supplied or intended to be sold or supplied; or
(b) substance or article used or intended to be used in the manufacture of a medicinal product.
(3) For the purposes of subarticle (1), an authorised person shall have the right:
(a) to inspect any records, in whatever form they are held, related to the manufacture, assembly, sale or supply of a medicinal product
and, where such records are kept in electronic form:
(i) may have access to, and inspect and check the operation of any computer, any associated apparatus or material which
is or has been in use in connection with the records; and
(ii) may require any person having charge of, or otherwise connected with the operation of, the
Power to inspect, take samples and seize goods and documents. Amended by:
XI. 2007.19.
such assistance as he may reasonably require;
(b) to take copies of any entry in any book or document produced in pursuance of the preceding paragraph and where the records are
kept electronically, by means of a computer or otherwise, require the records to be produced in an intelligible form which
may be taken away;
(c) to take photographs of any equipment, premises, records and documents.
(4) Any authorised officer shall have a right to seize, remove and detain any substance or article which he has reasonable cause
to believe to be a substance or article in relation to which, or by means of which, an offence under this Act is being or has been
committed, and any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings
under this Act.
(5) For the purpose of subarticle (4), any authorised person m a y, so far as is reasonably necessary in order to secure compliance
with the provisions of this Act and any regulations or rules m a de thereunder, require any person to b r eak open any container,
package or machine, or to permit him to do so:
Provided that where a person seizes any substance or art i cle, inclu d ing any d o cument, fo r th e purp o ses sp ecified
in subarticle (4), he shall inform the person from whom it is seized and give him a receipt thereof.
(6) Without prejudice to the preceding provisions of this article, any authorised person shall have the same rights conferred
by t h o s e pr ovi sio n s in rel a t i o n to t h i ngs bel o n g i ng to , o r an y bu si ness carried on b y, an appl ic ant
for an authorisation or certificate under Part III of this Act, and may exercise such rights for the purpo se of veri fying any statements
o r information contained in the application for the authorisation or certificate; and, where by v i rtu e o f the p r ovisio n s
of t h is subarti c le a person exercises any such right as is specified in subarticle (4), he shall be subject to the duty imposed
by subarticle (5).
(7) Notwithstanding anything in the preceding provisions of this article, where a person claiming to exercise a right by virtue
of the provisions of this article is required to produce his authorisation or credentials, the right shall only be exercisable by
him on the production of the authorisation or credentials.
(8) After every inspection the authorized officer shall report on whethe r the manufacturer complie s w i th th e p r in c i p
l es an d guidelines of good manufacturing practice or, where appropriate, with the requirements relating to pharmacovigilance. The
content of such reports shall b e comm uni cated to t h e manuf acturer or marketing authorisation holder who has undergone the inspection.
(9) Within ninety days of an inspection a certificate of good m anufacturing practice shall b e issued to a manufacturer if the
outcome of the inspection shows that the manufacturer complies
with the principles and guidelines of good manufacturing practice as provided for by legislation in force at the time.
102(4) and (6).
(2) If any person who in accordance with article 102(5) is entitled to be informed of the seizure so requests, either
at the time o f the sei z ure or at an y sub s eq uen t t ime, no t bein g later th an twenty-one days after he is informed of the
seizure, then subject to the following provisions of this article, the authorised officer shall either:
Application of sampling procedure to
substance or article seized.
Amended by:
XI. 2007.20;
XXIX. 2007.20.
(a) set aside a sample of the substance or article seized; or
(b) treat that substance or article as a sample,
whi c hever he consid ers m o re app r op ri ate h a vin g regard to th e nature of that substance or article.
(3) An authorised officer shall not be required by virtue of subarticle (2) to set aside a sample, or to treat a substance
or article as a sample, if the nature of the substance or article is such that it is not reasonably practicable to do either of those
things.
(4) Where in accordance with subarticle (2) an authorised officer sets aside a sample, or treat a substance or a r ticle
as a sample, he shall divide it into three parts, each part to be marked and sealed or fastened up in such manner as its nature will
permit, an d sh all su pp l y on e ex cerpt of i t to t h e p e rso n wh o mad e t h e request under subarticle (2).
(5) (a) Where any medicinal product has been seized under the p r ov isio ns of th is Act , and t h e o w ner th er eof consen ts i n
w r it in g t o t h e destructi o n of such medicinal product, the Licensing Authority may, after taking such samples as
may be required to prove the of fen ce, di rec t t h at t h e sai d me dici nal p r o duct b e destro yed w ith out prej udi ce
to the t a kin g of any p r oceedings agai nst the person responsible for the offence, and the said Licensing Authority shall recoup
all the expenses involved in t h e destruction of the medicinal product.
(b) In those cases where the owner fails to consent to the destruction of the medicinal product, the Licensing Authority may,
after filing an application requesting the Court to order the destruction at the expense of the owner, proceed with such destruction.
Supplementary provisions as to right of entry.
a ship, aircraft, vehicle, stall or place, is temporarily absent, leave it as effectively secured.
(2) The authorised officer shall also have such other powers as may be pr escrib ed by regulations made by the Minister for the
proper execution of his functions.
Proof of controls carried out. Added by:
XI. 2007.21.
(2) Manufacturers of immunological products shall submit to the Authority copies of all th e control reports signed by the qualified
person.
(3) Where the Authority considers it necessary in the interests of public health, it may require the holder of an authorization
for marketing -
(a) live vaccines,
(b) immunological medicinal products used in the primary immunization of infants or of other groups at risk,
(c) immunological medicinal products used in public health immunization programmes,
(d) new immunological medicinal products or immunological medicinal products manufactured using new or
altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing
authorization,
to submit samples from each batch of the bulk and, or the medicinal product for examination by a laboratory designated for that purpose
before release on to th e market unl ess, in th e case o f a batch manufactured in another Member State, the competent authority
of that Member State has previously examined the batch in question
and declared i t to b e in con f ormity with th e approved specifications. The Authority shall ensure that any su
ch
examination is completed within sixty days of the receipt of the samples.
(4) In the interests of public health, the Authority may require the marketing authorization holder for medicinal products derived
from human blood or human plasma to submit samples from each batch of the bulk and, or the medicinal product for testing by a laboratory
designated for that purpose before being released into fr ee circulation, unless the competent authorities o f another Member State
have previously examined the batch in question and declared it to be in conformity with the approved specifications. The Authority
shall ensure that any such examination is completed within sixty days of the receipt of the samples.
MISCELLANEOUS PROVISIONS
Recognition of equivalent standards.
Power of Minister to make regulations. Amended by:
XI. 2007.22.
(a) the grant of marketing authorisations;
(b) the manufacture of medicinal products and raw materials used in such manufacture;
(c) the wholesale distribution of medicinal products; (d) the sale and supply of medicinal products;
(e) the licensing of pharmacies;
(f) the reporting of adverse drug reactions;
(g) advertising in respect of medicinal products, and the presentation and information contained in the advert:
Provided that the advertising of certain medicinal products or classes of medicinal products may, by such regulations, be prohibited;
(h) the conduct of clinical trials;
(i) the classification of medicinal products; (j) the testing of medicinal products;
(k) the regulation of homeopathic medicinal products; radiopharmaceuticals and medicinal products derived from human blood
and human plasma; immunological products, and herbal products;
(l) the roles and responsibilities of a licence or authorisation holder;
(m) the roles and responsibilities of the managing pharmacist, responsible person and qualified person;
(n) standards of good practice in the manufacture, wholesale, distribution and dispensing of medicinal products:
Provided that in the case of dispensing the Minister may take the opinion of the Pharmacy Board;
(o) the recognition of equivalent standards for medicinal
product quality and efficacy in relation to such countries as may be prescribed;
(p) the recognition of equivalent standards for good practice in manufacture in relation to such countries as may be prescribed;
(q) the fees that may be levied and the funds wherein such fees may be deposited by the Licensing Authority, the Medicines Authority
and any other Committee established by or under this Act or regulations made thereunder;
(r) exceptions to any provision in the interest of public health.
Transitory provision.
Amendment of Medical and Kindred Professions Ordinance. Cap. 31.
Saving. Cap. 31.
Designation of competent authority. Added by: XXIX. 2007.21.
109. (1) Any regulations made under the provisions of the articles, of the Medical and Kindred Professions Ordinance, which have been repealed by article 108, shall, until provision is made under or by virtue of this Act, continue in force and have
effect as if made under this Act.
(2) Any licence, permission or other authorisation granted under any pr ovision of th e repealed articles as afor esaid,
shall continue in force thereafter as if it were a licence, permission or authorisation granted under a corresponding provision or
authority g r anted under this A c t and shall be treated and dealt w ith accordingly.
(3) Any action taken or proceedings commenced against or in relation to any person under the repealed articles as aforesaid shall
continue to have effect as if it were action or proceedings taken or commenced under a corresponding provision of this Act.
(2) Any such Order may delete any of the provisions of articles
5 and 7 to 13.
(3) Any such Order may also amend or delete subarticle (3) of article 3 and articles 4 and 6.
*this article was originally added as article 110 by Act XXIX. 2007.21.
(2) This Act shall be without prejudice to Council Decision 86/
346/EEC of 25 June 1986 accepting on behalf of the Community
the Europe an Agre ement on th e Exchange of Thera p eutic
Substances of Human Origin.
(3) The provisions of this Act shall not affect the powers of the A u th ori t y eit h er as regards t h e set tin g o f pr ices
f o r medi ci nal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic
and social conditions.
(4) This Act shall not affect the application of any law proh ibiti ng or restri ct ing t h e sal e , suppl y or use
of medicin a l products as contraceptives or abortifacients.
Saving provisions.
Added by:
XI. 2007.23.
FIRST SCHEDULE
(Deleted by Act III.2004.45)
SECOND SCHEDULE
Proceedings of the Medicines Review Board
1. All members of the Medicines Review Board shall be present for a hearing of an appeal or the development of a second
opinion.
2. All members of the Board shall have a vote and the opinion of the Board shall reflect the opinion of the majority of members:
Provided that a dissenting member may also request that his opinion be attached to the Board's opinion report as a minority report.
3. The appellant shall appear before the Board either in person or through an agent on the day and at the time fixed
for the hearing, make his submissions and produce such evidence as the Board may allow:
Provided that the Board may postpone the hearing of the appeal if it is satisfied that the appellant was prevented from appearing
before it owing to illness or absence from Malta or other similar reasonable cause.
4. The Board shall give the Medicines Authority an opportunity to make its submissions in justification of its
opinion/s, and bring such evidence as the Board may consider necessary.
5. The Board shall have the power to summon witnesses and to administer the oath to any person appearing before it.
6. The Board shall have power to confirm or issue a different opinion to that appealed against, as it may deem appropriate.
7. The opinion of the Board shall be final albeit not binding to the decision of the Licensing Aut horit y an d n o ap peal sh
all lie therefrom except on a question of law only.
8. Subject to the foregoing provisions and to the provisions of this Act, the Board shall regulate its own procedure.
THIRD SCHEDULE (Deleted by Act XI.2007.24)
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