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)
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
Annual 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 22
Repeal
Article 23
Entry into force
ANNEX I
Council Regulation (EEC) No 1768/92 |
|
Annex I, point XI.F.I, of the 1994 Act of Accession |
|
Annex II, point 4.C.II, of the 2003 Act of Accession |
|
Annex III, point 1.II, of the 2005 Act of Accession |
|
Regulation (EC) No 1901/2006 of the European Parliament and of the Council |
Only Article 52 |
ANNEX II
Regulation (EEC) No 1768/92 |
This Regulation |
— |
Recital 1 |
Recital 1 |
Recital 2 |
Recital 2 |
Recital 3 |
Recital 3 |
Recital 4 |
Recital 4 |
Recital 5 |
Recital 5 |
Recital 6 |
Recital 6 |
Recital 7 |
Recital 7 |
Recital 8 |
Recital 8 |
Recital 9 |
Recital 9 |
Recital 10 |
Recital 10 |
— |
Recital 11 |
— |
Recital 12 |
— |
Recital 13 |
Recital 11 |
Article 1 |
Article 1 |
Article 2 |
Article 2 |
Article 3, introductory wording |
Article 3, introductory wording |
Article 3, point (a) |
Article 3, point (a) |
Article 3, point (b), first sentence |
Article 3, point (b) |
Article 3, point (b), second sentence |
— |
Article 3, points (c) and (d) |
Article 3, points (c) and (d) |
Articles 4 to 7 |
Articles 4 to 7 |
Article 8(1) |
Article 8(1) |
Article 8(1a) |
Article 8(2) |
Article 8(1b) |
Article 8(3) |
Article 8(2) |
Article 8(4) |
Articles 9 to 12 |
Articles 9 to 12 |
Article 13(1), (2) and (3) |
Article 13(1), (2) and (3) |
Articles 14 and 15 |
Articles 14 and 15 |
Article 15a |
Article 16 |
Articles 16, 17 and 18 |
Articles 17, 18 and 19 |
Article 19 |
— |
Article 19a, introductory wording |
Article 20, introductory wording |
Article 19a, point (a), points (i) and (ii) |
Article 20, point (b), introductory wording, points (i) and (ii) |
Article 19a, point (b) |
Article 20, point (c) |
Article 19a, point (c) |
Article 20, point (d) |
Article 19a, point (d) |
Article 20, point (e) |
Article 19a, point (e) |
Article 20, point (f) |
Article 19a, point (f) |
Article 20, point (g) |
Article 19a, point (g) |
Article 20, point (h) |
Article 19a, point (h) |
Article 20, point (i) |
Article 19a, point (i) |
Article 20, point (k) |
Article 19a, point (j) |
Article 20, point (l) |
Article 19a, point (k) |
Article 20, point (a) |
Article 19a, point (l) |
Article 20, point (j) |
Article 20 |
Article 21 |
Article 21 |
— |
Article 22 |
Article 13(4) |
— |
Article 22 |
Article 23 |
Article 23 |
— |
Annex I |
— |
Annex II |