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Regulation (EEC) No 1768/92 is hereby amended as follows: 1) in Article 1, the following definition shall be added: ‘(e) “Application for an extension of the duration” means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and of Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (). 2) in Article 7, the following paragraphs shall be added: ‘3. The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Articles 8(1)(d) or 8(1a), respectively, are fulfilled.

4. The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate.

5. Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.’; 3) Article 8 shall be amended as follows:

(a) in paragraph 1, the following point shall be added: ‘(d) where the application for a certificate includes a request for an extension of the duration:

(i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006;

(ii) where necessary, in addition to the copy of the authorisations to place the product on the market as referred to in point (b), proof that it has authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006.’;

(b) the following paragraphs shall be inserted:

‘1a. Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) and a reference to the application for a certificate already filed.

1b. The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted.’;

(c) paragraph 2 shall be replaced by the following: ‘2. Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.’; 4) Article 9 shall be amended as follows:

(a) in paragraph 1, the following subparagraph shall be added: ‘The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned.’;

(b) in paragraph 2, the following point shall be added: ‘(f) where applicable, an indication that the application includes an application for an extension of the duration.’;

(c) the following paragraph shall be added:

‘3. Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate.’; 5) in Article 10, the following paragraph shall be added: ‘6. Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration.’; 6) in Article 11, the following paragraph shall be added: ‘3. Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected.’; 7) in Article 13, the following paragraph shall be added: ‘3. The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.’; 8) the following Article shall be inserted: ‘Article 15a Revocation of an extension of the duration

1. The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No 1901/2006.

2. Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent.’; 9) Article 16 shall be amended as follows:

(a) the text of Article 16 becomes that Article's paragraph 1;

(b) the following paragraph shall be added: ‘2. If the extension of the duration is revoked in accordance with Article 15a, notification thereof shall be published by the authority referred to in Article 9(1).’; 10) Article 17 shall be replaced by the following: ‘Article 17 Appeals The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 15a(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.’.