Manufacture and import of investigational medicinal products
Article 13
1
Member States shall take all appropriate measures to ensure that the manufacture or importation of investigational medicinal products is subject to the holding of authorisation.
The Commission shall lay down the minimum requirements which the applicant and, subsequently, the holder of the authorisation must meet in order to obtain the authorisation.
Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).
2
Member States shall take all appropriate measures to ensure that the holder of the authorisation referred to in paragraph 1 has permanently and continuously at his disposal the services of at least one qualified person who, in accordance with the conditions laid down in Article 23 of the second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products , is responsible in particular for carrying out the duties specified in paragraph 3 of this Article.
3
Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 21 of Directive 75/319/EEC, without prejudice to his relationship with the manufacturer or importer, is responsible, in the context of the procedures referred to in Article 25 of the said Directive, for ensuring:
a
in the case of investigational medicinal products manufactured in the Member State concerned, that each batch of medicinal products has been manufactured and checked in compliance with the requirements of Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use , the product specification file and the information notified pursuant to Article 9(2) of this Directive;
b
in the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/356/EEC, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to Article 9(2) of this Directive;
c
in the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorisation, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information notified pursuant to Article 9(2) of this Directive.
Detailed guidance on the elements to be taken into account when evaluating products with the object of releasing batches within the Community shall be drawn up pursuant to the good manufacturing practice guidelines, and in particular Annex 13 to the said guidelines. Such guidelines will be adopted in accordance with the procedure referred to in Article 21(2) of this Directive and published in accordance with Article 19a of Directive 75/319/EEC.
Insofar as the provisions laid down in (a), (b) or (c) are complied with, investigational medicinal products shall not have to undergo any further checks if they are imported into another Member State together with batch release certification signed by the qualified person.
4
In all cases, the qualified person must certify in a register or equivalent document that each production batch satisfies the provisions of this Article. The said register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the agents of the competent authority for the period specified in the provisions of the Member States concerned. This period shall in any event be not less than five years.
5
Any person engaging in activities as the qualified person referred to in Article 21 of Directive 75/319/EEC as regards investigational medicinal products at the time when this Directive is applied in the Member State where that person is, but without complying with the conditions laid down in Articles 23 and 24 of that Directive, shall be authorised to continue those activities in the Member State concerned.
OJ L 147, 9.6.1975, p. 13. Directive as last amended by Council Directive 93/39/EC (OJ L 214, 24.8.1993, p. 22).
OJ L 193, 17.7.1991, p. 30.
Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Four.