S.L. 458.36 ст. 7Obligation of licence holder.

(1) The holder of the licence, apart from his obligations in article 44 of the Act, shall:

(a) comply with the Community principles and guidelines of good manufacturing practice and any annexes thereof for medicinal products and use only active substances which have been manufactured in accordance with the Community guidelines on good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances. To this end, the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances. The holder of the manufacturing authorisation shall verify such compliance either by himself or, without prejudice to his responsibility as provided for in these regulations and in the Act , through an entity acting on his behalf under a contract;

(b) ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is. This shall be ascertained on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the fifth paragraph of Article 47 of Directive 2001/83/EC, as amended. Such risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects. The holder of the manufacturing authorisation shall ensure that the appropriate good manufacturing practice, so ascertained, is applied. The holder of the manufacturing authorisation shall document the measures taken under this paragraph;

(c) inform the competent authority and the marketing authorisation holder immediately if he obtains information that medicinal products which come under the scope of his manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services;

(d) verify that the manufacturers, importers or distributors from whom he obtains active substances are registered with the competent authority of the Member State in which they are established;

(e) verify the authenticity and quality of the active substances and the excipients.

(2) For the purposes of this regulation, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material as defined in Part I, point 3.2.1.1 (b) Annex I of Directive 2001/83, and the various processes of dividing up, packaging or presentation prior to its incorporation into a medicinal product, including repackaging or re-labelling, such as are carried out by a distributor of starting materials.

(3) The safety features referred to in regulation 3(o) of the Medicinal Products (Labelling and Packaging) Regulations shall not be removed or covered, either fully or partially, unless the following conditions are fulfilled:

(a) the manufacturing licence holder verifies, prior to partly or fully removing or covering those safety features, that the medicinal product concerned is authentic and that it has not been tampered with;

(b) the manufacturing licence holder complies with regulation 3(o) of the Medicinal Products (Labelling and Packaging) Regulations, by replacing those safety features with safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering of the medicinal product. Such replacement shall be conducted without opening the immediate packaging. Safety features shall be considered equivalent if they:

(i) comply with the requirements as may be adopted by the European Union Commission pursuant to Article 54a(2) of Directive 2001/83/EC as amended; and

(ii) are equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products;

(c) the replacement of the safety features is conducted in accordance with applicable good manufacturing practice for medicinal products; and

(d) the replacement of the safety features is subject to supervision by the Licensing Authority through inspections or any other means as may be determined by the same Authority.

(4) Manufacturing licence holders, including those performing the activities referred to in sub-regulation (3), shall be regarded as producers and therefore held liable for damages in the cases and under the conditions set forth in the Consumers Affairs Act.

(5) It shall be the duty of the importer to ensure that:

(a) in the case of medicinal products and investigational medicinal products imported from third countries, these have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down by the Community;

(b) in the case of medicinal products, such products have been manufactured by manufacturers duly authorised for the purpose; and

(c) in the case of investigational medicinal products, such products have been manufactured by a manufacturer notified to the competent authorities and accepted by them for that purpose.