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  3. SPC Regulation for Medicinal Products

SPC Regulation for Medicinal Products

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Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (Text with EEA relevance)

 

Preamble

 

Article 1 - Definitions

 

Article 2 - Scope

 

Article 3 - Conditions for obtaining a certificate

 

Article 4 - Subject matter of protection

 

Article 5 - Effects of the certificate

 

Article 6 - Entitlement to the certificate

 

Article 7 - Application for a certificate

 

Article 8 - Content of the application for a certificate

 

Article 9 - Lodging of an application for a certificate

 

Article 10 - Grant of the certificate or rejection of the application for a certificate

 

Article 11 - Publication

 

Article 12 - Fees

 

Article 13 - Duration of the certificate

 

Article 14 - Expiry of the certificate

 

Article 15 - Invalidity of the certificate

 

Article 16 - Revocation of an extension of the duration

 

Article 17 - Notification of lapse or invalidity

 

Article 18 - Appeals

 

Article 19 - Procedure

 

Article 20 - Additional provisions relating to the enlargement of the Community

 

Article 21 - Transitional provisions

 

Article 21a - Evaluation

 

Article 22 - Repeal

 

Article 23 - Entry into force

 

Annex I

 

Annex -I

 

Annex -Ia

 

Annex II

 

 

Disclaimer

Text in force at 01-04-2026. The text can be verified at EUR-LEX. Titles of articles have been added for convenience, but are lacking in the official text, IP-PorTal.

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