Commission Directive 2005/28/ECShow full title

CHAPTER 3 MANUFACTURING OR IMPORT AUTHORISATION

Article 9

1. Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall be required for both total and partial manufacture of investigational medicinal products, and for the various processes of dividing up, packaging or presentation. Such authorisation shall be required even if the products manufactured are intended for export.

Authorisation shall also be required for imports from third countries into a Member State.

2. Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall not be required for reconstitution prior to use or packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member States to carry out such processes and if the investigational medicinal products are intended to be used exclusively in those institutions.

Article 10

1. In order to obtain the authorisation the applicant must meet at least the following requirements:

(a) specify in his application the types of medicinal products and pharmaceutical forms to be manufactured or imported;

(b) specify in his application the relevant manufacture or import operations;

(c) specify in his application, where relevant as in the case of viral or non-conventional agents’ inactivation, the manufacturing process;

(d) specify in his application the place where the products are to be manufactured or have at his disposal, for their manufacture or importation, suitable and sufficient premises, technical equipment and control facilities complying with the requirements of Directive 2003/94/EC as regards the manufacture, control and storage of the products;

(e) have permanently and continuously at his disposal the services of at least one qualified person as referred to in Article 13(2) of Directive 2001/20/EC.

For the purposes of point (a) of the first subparagraph, ‘types of medicinal products’ include blood products, immunological products, cell therapy products, gene therapy products, biotechnology products, human or animal extracted products, herbal products, homeopathic products, radiopharmaceutical products and products containing chemical active ingredients.

2. The applicant shall provide with his application documentary evidence that he complies with paragraph 1.

Article 11

1. The competent authority shall issue the authorisation only after verifying the accuracy of the particulars provided by the applicant pursuant to Article 10 by the means of an inquiry carried out by its agents.

2. Member States shall take all appropriate measures to ensure that the procedure for granting an authorisation is completed within 90 days of the day on which the competent authority receives a valid application.

3. The competent authority of the Member State may require from the applicant further information concerning the particulars supplied pursuant to Article 10(1), including in particular information concerning the qualified person at the disposal of the applicant in accordance with point (e) of Article 10(1).

Where the competent authority concerned exercises that right, the application of the time-limits laid down in paragraph 2 shall be suspended until the additional data required have been supplied.

Article 12

1. In order to ensure that the requirements laid down in Article 10 are complied with, authorisation may be made conditional on the carrying out of certain obligations imposed either when authorisation is granted or at a later date.

2. An authorisation shall apply only to the premises specified in the application and to the types of medicinal products and pharmaceutical forms specified in that application pursuant to point (a) of Article 10(1).

Article 13

The holder of the authorisation shall at least comply with the following requirements:

(a)

to have at his disposal the services of staff that comply with the legal requirements existing in the Member State concerned both as regards manufacture and controls;

(b)

to dispose of the investigational/authorised medicinal products only in accordance with the legislation of the Member State concerned;

(c)

to give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied pursuant Article 10(1) and, in particular, to inform the competent authority immediately if the qualified person referred to in Article 13(2) of Directive 2001/20/EC is replaced unexpectedly;

(d)

to allow agents of the competent authority of the Member State concerned access to his premises at any time;

(e)

to enable the qualified person referred to in Article 13(2) of Directive 2001/20/EC to carry out his duties, for example by placing at his disposal all the necessary facilities;

(f)

to comply with the principles and guidelines for good manufacturing practice for medicinal products as laid down by Community law.

Detailed guidelines in line with the principles referred to in point (f) of the first paragraph will be published by the Commission and revised where necessary to take account of technical and scientific progress.

Article 14

If the holder of the authorisation requests a change in any of the particulars referred to in points (a) to (e) of Article 10(1), the time taken for the procedure relating to the request shall not exceed 30 days. In exceptional cases, this period of time may be extended to 90 days.

Article 15

The competent authority shall suspend or revoke the authorisation, as a whole or in part, if the holder of the authorisation fails at any time to comply with the relevant requirements.