Regulation (EC) No 816/2006

In force

This text since 19 Jan 2026law://eu/reg/2006/816/art_16__para_4@2026-11-15

Contents

4.When notified by the importing country that the amount of pharmaceutical product has become insufficient to meet its needs, the competent authority may, following an application by the licensee, modify the conditions of the licence permitting the manufacture and export of additional quantities of the product to the extent necessary to meet the needs of the importing country concerned. In such cases the licensee's application shall be processed in accordance with a simplified and accelerated procedure, whereby the information set out in Article 6(3), points (a) and (b), shall not be required provided that the original compulsory licence is identified by the licensee. In situations where Article 9(1) applies but the derogation set out in Article 9(2) does not apply, no further evidence of negotiation with the rights-holder will be required, provided that the additional amount requested does not exceed 25 % of the amount granted under the original licence.In situations where Article 9(2) applies, no evidence of negotiation with the rights-holder will be required.

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

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Cited by 2: this act; Regulation (EU) 2025/26455 provisions
Cites 1: this act3 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;