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Authority may, after filing an application requesting the Court to order the destruction at the expense of the owner, proceed with such destruction.

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Art. 104

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104.(1) Any person entering any property or any other premises, ship, aircraft, stall or place in accordance with the provisions of article 101, may be accompanied by such other person o r ta ke such e qui pm en t as may a pp ear t o h im to b e necessary; and on leaving any such property shall, if the property is unoccupied or the occupier or any other person who is in charge of a ship, aircraft, vehicle, stall or place, is temporarily absent, leave it as effectively secured.
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Supplementary provisions as to right of entry.

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(2)The authorised officer shall also have such other powers as may be prescribed by regulations made by the Minister for the proper execution of his functions.
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Art. 104A

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104A. Any person who, by any means whatsoever, hinders or obstructs the Licensing Authority or an authorised officer from exercising any of his powers and functions under this Act shall be guilty of an offence against this Act.

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Hindering, etc., the Licensing Authority.

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Added by:

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V. 2013.32.

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Art. 104B

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104B. (1) The holder of the marketing authorization for a medicinal product and, where appropriate, the holder of the manufacturing authorization, shall furnish proof of the controls carried out on the medicinal product and, or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down in Article 8(3)(h) of Directive 2001/83/EC and any amendments thereto.

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Proof of controls carried out.

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Added by:

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XI. 2007.21.

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Re-numbered by:

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V. 2013.31.

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(2)Manufacturers of immunological products shall submit to MEDICINES the Authority copies of all the control reports signed by the qualified person.
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(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 the market unless, in the case of a batch manufactured in another Member State, the competent authority of that Member State has 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.
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(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 free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications.
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The Authority shall ensure that any such examination is completed within sixty days of the receipt of the samples.

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Recalls and rapid alerts.

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Added by:

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V. 2013.33.

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Art. 104C

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104C. (1) The Licensing Authority shall ensure that there is a system in place which aims at preventing medicinal products that are suspected to present a danger to health from reaching the patient.

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(2)The system referred to in sub-article (1) shall cover the receipt and handling of notifications of suspected falsified medicinal products as well as of suspected quality defects of m ed ici na l prod uct s. Th e sy stem shal l also c ove r re call s o f medicinal products by marketing authorisation holders or withdrawals of medicinal products from the market ordered by national competent authorities from all relevant actors in the supply chain both during and outside normal working hours. The system shall also make it possible to recall, where necessary with the assistance of health professionals, medicinal products from patients who received such products.
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ME DICINE S

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(3)If the medicinal product in question is suspected of presenting a serious risk to public health, the Licensing Authority shall, without any delay, transmit a rapid alert notification to all European Union Member States and all actors in the supply chain in Malta. In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within twenty-four hours in order to recall those medicinal products from the patients. Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.
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PART VIII

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MISCELLANEOUS PROVISIONS

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Art. 105

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105.For the purposes of this Act, the Minister may, on the advice of the Licensing Authority, by regulations prescribe that a provision or provisions in relation to the marketing authorisation of a medicinal product shall be deemed to be satisfied, if the standards of manufacture, medicinal product quality, safety or efficacy, or the provisions in relation to the granting of a marketing authorisation of a country designated in such regulations, are satisfied.
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Recognition of equivalent standards.

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Art. 106

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106.The Minister may, after consultation with the Licensing Authority, amend the schedules to this Act, prescribe by regulations anything that may be prescribed under this Act and make provision o n a n y m a t t e r r e l at i n g t o m e d i c i n a l p r o d u c t s , p o i s o n s a n d pharmacies in order to give fuller effect to the provisions of this Act, and, in particular, but without prejudice to the generality of the aforesaid, shall by such regulations regulate or otherwise provide for:
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Power of Minister to make regulations.

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Amended by:

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XI. 2007.22;

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VII.2020.2. (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:

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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 MEDICINES 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:

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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) the regulation of the use of medical devices for medical and, or research purposes, but without prejudice to the generality of this paragraph, the Minister may make regulations for all or any of the following purposes: (i) for prescribing the conditions under which the authorisations may be granted, renewed, suspended, transferred or cancelled; (ii) for providing the manner in which applications for the grant, renewal, suspension, transfer or cancellation of the authorisations or of any one or more categories or classes thereof are to be made; (iii) for providing the manner in which applications for such authorisations and approvals as may be prescribed are to be publicised and for providing the manner in which any person who may be prejudiced by such the authorisations and approvals may make an objection or representation thereon; (iv) for establishing the duration of the validity of the authorisations or of any one or more categories or classes thereof; (v) for establishing the qualifications that certain key personnel involved in or with the premises may be required to possess; (vi) for regulating inspections to be carried out at the premises; (vii) for prescribing the inventory controls, registers, records and databases that have to be kept by the ME DICINE S licence holder at the premises and any financial guarantees which the licence holder shall have to give; (viii) for the establishment of quality controls and quality assurances, other than those already established under this Act, and any matter in relation to any activity carried on any premises or by any person licensed under this legislation; (ix) for establishing the fees leviable in respect of the authorisations, approvals and for any other service provided by the Medicines Authority such as scientific advice or other work as may be deemed necessary for the Medicines Authority to carry out its function:

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Provided that regulations made under this subparagraph may establish the minimum and the maximum of any fees leviable in respect of the authorisations, approvals and for any other service provided by the Medicines Authority such as scientific advice or other work as may be deemed necessary for the Medicines Authority to carry out its function; and (x) for establishing the penalties or administrative sanctions to which any offender against the provisions of this Act or any regulations made thereunder shall be liable; (s) the establishing of offences and the relative penalty in relation to the contravention of any provisions of this Act or regulations issued under this Act which penalty shall not be less than a fine (multa) of twelve thousand euro (€12,000) and not exceeding one hundred and twenty thousand euro (€120,000) or to imprisonment for a term not exceeding two years, or to both such fine and imprisonment; (t) exceptions to any provision in the interest of public health.

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Art. 107

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107.Any medicinal products on the market on the date of the coming into force of article 20 shall only be subject to the provisions of that article at such time and subject to such conditions as may by rules be established by the Licensing Authority.
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Art. 108

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108.Omitted under the Statute Law Revision Act, 1980.
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Art. 109

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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.
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Transitory provision.

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Amendment of Medical and Kindred Professions Ordinance.

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Saving.

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MEDICINES

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(2)Any licence, permission or other authorisation granted under any provision of the repealed articles as aforesaid, shall continue in force thereafter as if it were a licence, permission or authorisation granted under a corresponding provision or authority granted under this Act and shall be treated and dealt with accordingly.
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(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.
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Designation of competent authority.

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Added by:

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XXIX. 2007.21.

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109A. * (1) The Prime Minister may, following consultation with the Minister responsible for health, by Order in the Gazette designate any authority to carry out the functions carried out by the Medicines Authority under this Act.

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(2)Any such Order may delete any of the provisions of articles 5 and 7 to 13.
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(3)Any such Order may also amend or delete subarticle (3) of article 3 and articles 4 and 6.
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Saving provisions.

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Added by:

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XI. 2007.23.

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Art. 110

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110.(1) Nothing in this Act shall in any way derogate from any Acts or regulations for the radiation protection of persons u n d e rg o in g m e d i c a l e x a m i n a t i o n o r t r e a tm en t , or f r o m t he Community rules laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation.
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(2)This Act shall be without prejudice to Council Decision 86/ 346/EEC of 25 June 1986 accepting on behalf of the Community the European Agreement on the Exchange of Therapeutic Substances of Human Origin.
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(3)The provisions of this Act shall not affect the powers of the Authority either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions.
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(4)This Act shall not affect the application of any law prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients.
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Medical devices and in vitro diagnostic medical devices.

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Added by:

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XXXV.2020.2.

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Art. 111

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111.Any regulations issued under the Product Safety Act dealing with medical devices and in vitro diagnostic medical devices shall be deemed to have been issued under this Act.
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Language.

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Added by:

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XXXV.2020.2.

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Art. 112

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112.Regulations made under any provision of this Act may be made in the English language only. *this article was originally added as article 110 by Act XXIX. 2007.21.
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ME DICINE S FIRST SCHEDULE (Deleted by Act III.2004.45) SECOND SCHEDULE Proceedings of the Medicines Review Board 1.

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All members of the Medicines Review Board shall be present for a hearing of an appeal or the development of a second opinion.

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2.

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All members of the Board shall have a vote and the opinion of the Board shall reflect the opinion of the majority of members:

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Provided that a dissenting member may also request that his opinion be attached to the Board's opinion report as a minority report.

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3.

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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:

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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.

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4.

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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.

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5.

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The Board shall have the power to summon witnesses and to administer the oath to any person appearing before it.

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6.

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The Board shall have power to confirm or issue a different opinion to that appealed against, as it may deem appropriate.

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7.

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The opinion of the Board shall be final albeit not binding to the decision of the Licensing Authority and no appeal shall lie therefrom except on a question of law only.

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8.

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Subject to the foregoing provisions and to the provisions of this Act, the Board shall regulate its own procedure.

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THIRD SCHEDULE (Deleted by Act XI.2007.24)

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