# Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, Article 6: Application for a compulsory licence

Extent: E+W+S+N.I.

1. Any person may submit an application for a compulsory licence under this Regulation to the competent authority in a case where that person's intended activities of manufacture and sale for export are covered by a patent or a supplementary protection certificate.
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 the application made to the competent authority, 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/eur/2006/816/article/6 (the official version)
Page: https://openlegislation.uk/eu-regulation-2006-816/article-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.