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Regulation (EC) No 469/2009 of the European Parliament and of the CouncilShow full title

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)

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  1. Introductory Text

  2. Article 1.Definitions

  3. Article 2.Scope

  4. Article 3.Conditions for obtaining a certificate

  5. Article 4.Subject matter of protection

  6. Article 5.Effects of the certificate

  7. Article 6.Entitlement to the certificate

  8. Article 7.Application for a certificate

  9. Article 8.Content of the application for a certificate

  10. Article 9.Lodging of an application for a certificate

  11. Article 10.Grant of the certificate or rejection of the application for a certificate

  12. Article 11.Publication

  13. Article 12.Fees

  14. Article 13.Duration of the certificate

  15. Article 13A.Authorisation granted after submission of an application for a certificate

  16. Article 13B.Extension of the duration of a certificate

  17. Article 14.Expiry of the certificate

  18. Article 15.Invalidity of the certificate

  19. Article 16.Revocation of an extension of the duration

  20. Article 17.Notification of lapse or invalidity

  21. Article 18.Appeals

  22. Article 19.Procedure

  23. Article 19A.Transitional provisions

  24. Article 20.Additional provisions relating to the enlargement of the Community

  25. Article 21.Transitional provisions

  26. Article 21a.Evaluation

  27. Article 22.Repeal

  28. Article 23.Entry into force

  29. Signature

    1. Expand +/Collapse -

      ANNEX I

    2. Expand +/Collapse -

      ANNEX -I

      Logo

    3. Expand +/Collapse -

      ANNEX -Ia

      1. Standard form for notification pursuant to points (b) and (c)...

    4. Expand +/Collapse -

      ANNEX II

    5. Expand +/Collapse -

      ANNEX III

      Transitional provisions in relation to applications and certificates for medicinal products for human use concerning the implementation of the Windsor Framework

      1. 1. New applications

      2. 2. Certificates in effect in Northern Ireland

      3. 3. Notification of authorisations

      4. 4. Lapse or withdrawal of certificates

      5. 5. Paediatric extensions

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