Regulation (EC) No 816/2006

In force

This text since 19 Jan 2026law://eu/reg/2006/816/art_9@2026-11-15

Contents

Article 9Prior negotiation#

1.The applicant shall provide evidence to satisfy the competent authority that he has made efforts to obtain authorisation from the rights-holder and that such efforts have not been successful within a period of thirty days before submitting the application.

2.The requirement in paragraph 1 shall not apply in situations of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use under Article 31(b) of the TRIPS Agreement.

Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.

Key facts

Type: Regulation · (EC) No 816/2006
Adopted: 17 May 2006
In force: 29 Jun 2006
Text current to: 19 Jan 2026
Made by: Council of the European Union, European Parliament
Official: EUR-Lex 32006R0816 · ELI

Topics

export monitoring health aid least-developed country patents licence pharmaceutical product Approximation of laws Commercial policy Industry Others

History · 1 version

19 Jan 2026Reading

Connections

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Cited by 2: this act3 provisions; Regulation (EU) 2025/26455 provisions

Defined terms · 3

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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;