Article 6 · Regulation (EC) No 816/2006

Contents

Article 6Application for a compulsory licence#

1.Any person may submit an application for a compulsory licence under this Regulation to a competent authority in the Member State or States where patents or supplementary protection certificates have effect and cover his intended activities of manufacture and sale for export.

2.If the person applying for a compulsory licence is submitting applications to authorities in more than one country for the same product, he shall indicate that fact in each application, together with details of the quantities and importing countries concerned.

3.The application pursuant to paragraph 1 shall set out the following:

(a)the name and contact details of the applicant and of any agent or representative whom the applicant has appointed to act for him before the competent authority;

(b)the non-proprietary name of the pharmaceutical product or products which the applicant intends to manufacture and sell for export under the compulsory licence;

(c)the amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;

(d)the importing country or countries;

(e)where applicable, evidence of prior negotiation with the rights-holder pursuant to Article 9;

(f)evidence of a specific request from:

(i)authorised representatives of the importing country or countries; or

(ii)a non-governmental organisation acting with the formal authorisation of one or more importing countries; or

(iii)UN bodies or other international health organisations acting with the formal authorisation of one or more importing countries,

indicating the quantity of product required.

4.Purely formal or administrative requirements necessary for the efficient processing of the application may be prescribed under national law. Such requirements shall not add unnecessarily to the costs or burdens placed upon the applicant and, in any event, shall not render the procedure for granting compulsory licences under this Regulation more burdensome than the procedure for the granting of other compulsory licences under national law.

Defined terms · 3

Show every defined term

importing country
means the country to which the pharmaceutical product is to be exported;
pharmaceutical product
means any product of the pharmaceutical sector, including medicinal products as defined in Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, active ingredients and diagnostic kits ex vivo;
rights-holder
means the holder of any patent or supplementary protection certificate in relation to which a compulsory licence has been applied for under this Regulation;

Regulation (EC) No 816/2006

Article 6Application for a compulsory licence#

Defined terms · 3

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Article 6Application for a compulsory licence#

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