WRITTEN QUESTION P-0064/00

by Peter Skinner (PSE) to the Commission

(18 January 2000)

Subject: Definition of fundamental change in pharmaceutical products

Commission Regulation (EC) No 541/95(1) states that certain changes to the terms of a pharmaceutical product marketing authorisation are fundamental and as such require that a new, complete scientific evaluation be conducted (such as in the case of replacement of the active substance by a different salt/ester.

Can the Commission confirm that:

1. The rationale for defining fundamental changes and requiring them to be the subject of new applications rather than variation applications was that special scrutiny of the research data relating to that change would be required by the competent authorities before it could properly be concluded that the public health criteria of quality, safety and efficacy were still met for the production in question, and

2. In principle the same cautious approach should apply if the same fundamental differences exist between two products where it is claimed that one is a generic copy of the other and that that copy can be authorised on the basis of the research data generated for the first product?

(1) OJ L 55, 11.3.1995, p. 7.

Answer given by Mr Liikanen on behalf of the Commission

(11 February 2000)

Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State, and Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/93(1), as amended(2), lay down rules governing the examination of variations to a marketing authorisation granted for a medicinal product by either of the following Community procedures: the mutual recognition procedure or the centralised procedure.

The Regulations provide for three types of variation to the terms of a marketing authorisation, depending on their importance and the time allowed for their assessment: minor variations (type I), listed in Annex I, major variations (type II) and changes which fundamentally alter the

terms of the authorisation. The latter must be approved by a complete assessment procedure similar to that for new applications for marketing authorisation and the assessment period (210 days) is exactly the same as that for new applications. Such changes are listed in Annex II. They include changes to the active substance(s), the therapeutic indications or the strength, pharmaceutical form and route of administration. However, it should be noted that even these are always variations to an authorisation which has already been granted for a given medicinal product.

With regard to the examination of data, the same criteria of quality, safety and efficacy must be met in all cases.

The same assessment criteria of quality, safety and efficacy apply to generic products. The applicant can be exempted from safety and efficacy trials only if he can show that the product for which the authorisation has been requested is essentially the same as another products which already has a marketing authorisation.

(1) OJ L 55, 11.3.1995.

(2) OJ L 159, 3.6.1998.