Manufacture and Import of Investigational Medicinal Product

An authorization shall be required for both total and partial manufacture and for the various processes of dividing up, packaging, and presentation. In order to obtain this authorization, the applicant must meet at least the following requirements:

  • Specify the types of products to be manufactured or imported and the manufacturing or import operations concerned and the manufacturing process and also the place where these products are to be manufactured and/or controlled.
  • Have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the requirements of the GMP Commission Directive 91/356/EEC now 2003/94/EC, as regards both manufacture and control and the storage of products referred to in the paragraph.
  • Have at his disposal the services of at least one Qualified Person.


The holder of the said authorization shall at least be obliged:

  • To have at his disposal the services of staff who comply with the legal requirements existing in the Member State concerned, both as regards manufacture and controls.
  • To dispose of the Investigational Medicinal Products only in accordance with the legislation of the Member States concerned.
  • To give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied; the competent authority shall, in any event, be immediately informed if the Qualified Person referred to in article 13.2 f Parliament and Council Directive 2001/20/EC is replaced unexpectedly.
  • To allow agents of the competent authority of the Member State concerned access to his premises at any time.
  • To enable the Qualified Person referred to in article 13.2 of Parliament and Council Directive 2001/20/EC to carry out his duties, for example by placing at his disposal all the necessary facilities.
  • To comply with the principles and guidelines of Good Manufacturing Practice for medicinal products as laid down by Community Law.

The competent authority of the Member State shall issue the authorization only after having made sure of the accuracy of the particulars supplied by means of an inquiry carried out by its agents.

Site information should compose of the following:

1.    The address of the site.

2.    Evidence that the premises are legally occupied.

3.    A description of all activities which are not connected with medicinal products carried out on the site.

4.    A description of all pharmaceutical activities (manufacturing and/pr import operations) which will be carried out on the site and a description of related types of products and manufacturing processes.

5.    A general description of the premises and a precise description of each of the different areas in which the manufacturing or import operations are carried out (production, packaging, blinding, quality control and storage)

6.    A description of the technical equipment used for each type of product and manufacturing process and its location.

7.    A description of control facilities.


Qualified Person(s) Information should consist of the following:

1.    The name of the Qualified Person(s) referred to in article 13.2 of Parliament and Council Directive 2001/20/EC

2.    All certificated concerning his/her eligibility: evidence of formal qualifications and of practical experience (diploma, certificate)

3.    A statement regarding his/her function on the site where he/she is not a permanent employee of the proposed authorization holder.

4.    A statement of organizational chart specifying areas of responsibility, relating to persons responsible for production and quality control

Good Manufacturing Practice

  • “Member states shall take all appropriate measures to ensure that the manufacture... of investigational medicinal products... meets the requirements of Directive 91/356/EEC – i.e., GMP now 2003/94/EEC
  • Applies to EU manufacture and to Third Country manufacture
  • Note that re-testing is not required on importation from a third country if the GMP equivalence statement is available.
  • IMPs must be in accordance with the product specification file.
  • Comparators from a Third Country whereby a statement cannot be obtained concerning the GMP of manufacture must undergo all relevant analysis, tests, or checks necessary to confirm its quality.
  • Detailed guidance has been published on the elements to be taken into account when evaluating products with the object of releasing batches within the EU, reference revised Annex 13

Qualified Persons must have QP as per 75/319/EEC (2001/20/EEC), a transitional arrangement for QPs were established and QP must keep a register.