Keywords

Summary



Keywords

1. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Testing of medicinal products – Examination on the basis of all the data in the possession of the competent authority

(Council Directive 65/65, Arts 4.8(a)(iii) and 5, first subpara.)

2. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Bioequivalent products

(Council Directive 65/65, Art. 4.8(a)(i) and (iii))

3. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Abridged procedure – Essentially similar products – Determination of the pharmaceutical form of the medicinal product – Consideration of the form in which it is presented and administered, including the physical form

(Council Directive 65/65, Art. 4.8(a)(i) and (iii))

4. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Hybrid abridged procedure – Scope – Conditions – Essentially similar products – Limits

(Council Directive 65/65, Art. 4.8(a)(i), (iii) and final subpara.)

5. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Abridged procedure – Reference product when considering request for authorisation – Right of competent authority to refer to data of a product authorised under the hybrid abridged procedure

(Council Directive 65/65, Art. 4.8(a)(iii) and final subpara.)

6. Approximation of laws – Proprietary medicinal products – Marketing authorisation – Hybrid abridged procedure – Consideration of two requests for authorisation in respect of the same product – Requirement for different data for each request – Principle of non-discrimination – Infringement – Absence

(Council Directive 65/65, Art. 4.8(a) and last para.)

Summary

1. In accordance with the first recital in the preamble to Directive 65/65 relating to medicinal products, as amended by Directives 87/21, 89/341 and 93/39, the primary purpose of any rules concerning the production and distribution of medicinal products must be to safeguard public health. Where the competent authority of a Member State making a decision on an application for marketing authorisation examines the safety and efficacy of the medicinal product, it is permissible for that authority to take account of all data in its possession, from whatever source, to the extent that such data demonstrate that the product is harmful or that it lacks efficacy. Accordingly, and pursuant to the first subparagraph of Article 5 of Directive 65/65, an application for marketing authorisation must be refused, inter alia, where, on the basis of data in the possession of the competent authority, it appears that a medicinal product is harmful or lacks efficacy. Clearly the competent authority is not precluded from basing its refusal on data submitted by other applicants, even if that data is protected within the meaning of Article 4.8(a)(iii) of the Directive.

(see paras 29-31)

2. Products cannot be regarded as essentially similar for the purposes of the application of Article 4.8(a)(i) or (iii) of Directive 65/65 relating to medicinal products, as amended by Directives 87/21, 89/341 and 93/39, where they are not bioequivalent.

(see para. 35, operative part 1)

3. For the purposes of the procedure laid down by Article 4.8(a)(i) and (iii) of Directive 65/65 relating to medicinal products, as amended by Directives 87/21, 89/341 and 93/39, in determining the pharmaceutical form of a medicinal product, account must be taken of the form in which it is presented and the form in which it is administered, including the physical form. In that context, medicinal products which are presented in the form of a solution to be mixed in a drink for administration to the patient and which, after mixing, form, respectively, a macroemulsion, a microemulsion and a nanodispersion, are to be treated as having the same pharmaceutical form, provided that the differences in the form of administration are not significant in scientific terms.

(see para. 42, operative part 2)

4. The proviso, that is, the hybrid abridged procedure laid down by the final subparagraph of Article 4.8(a) of Directive 65/65 relating to medicinal products, as amended by Directives 87/21, 89/341 and 93/39, applies to applications for marketing authorisation based on Article 4.8(a)(i) or (iii).

An application for marketing authorisation for a medicinal product may be made under the proviso, with reference to an authorised medicinal product provided that the medicinal product in respect of which marketing authorisation is sought is essentially similar to the authorised medicinal product, unless one or more of the differences set out in the proviso apply, as the case may be.

(see paras 47, 55, operative part 3)

5. In considering an application for marketing authorisation for a new product C under Article 4.8(a)(iii) of Directive 65/65 relating to medicinal products, as amended by Directives 87/21, 89/341 and 93/39, with reference to a product A authorised for more than six or 10 years, the competent authority of a Member State is entitled, with a view to granting marketing authorisation, to refer without the consent of the person responsible for marketing to data submitted in support of a product B which was authorised within the previous six or 10 years under the hybrid abridged procedure laid down by Article 4.8(a) of Directive 65/65, with reference to product A, where those data consist of clinical trials provided in order to demonstrate that product B, though suprabioavailable to product A when administered in the same dose, is safe.

(see para. 67, operative part 4)

6. In considering two hybrid applications for marketing authorisation for products B and C brought under the final subparagraph of Article 4.8(a) of Directive 65/65 relating to medicinal products, as amended by Directives 87/21, 89/341 and 93/39, and referring to product A, the competent authority of a Member State does not infringe the principle of non-discrimination where, as a precondition for the grant of marketing authorisation, it requires full clinical data on the bioavailability of product B, but, having examined the data filed in support of product B, does not require the same data for product C.

(see para. 72, operative part 5)