Regulation (EC) No 1901/2006 of the European Parliament and of the CouncilShow full title

TITLE VII U.K. GENERAL AND FINAL PROVISIONS

CHAPTER 1 U.K. General provisions

Section 1 U.K. Fees, community funding, penalties and reports

Article 47 U.K.

1. Where an application for a paediatric use marketing authorisation is submitted in accordance with the procedure laid down in Regulation (EC) No 726/2004, the amount of the reduced fees for the examination of the application and the maintenance of the marketing authorisation shall be fixed in accordance with Article 70 of Regulation (EC) No 726/2004.

2. Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Medicines Agency(1) shall apply.

3. Assessments of the following by the Paediatric Committee shall be free of charge:

(a) applications for waiver;

(b) applications for deferral;

(c) paediatric investigation plans;

(d) compliance with the agreed paediatric investigation plan.

Article 48 U.K.

The Community contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall cover the work of the Paediatric Committee, including scientific support provided by experts, and of the Agency, including the assessment of paediatric investigation plans, scientific advice and any fee waivers provided for in this Regulation, and shall support the Agency's activities under Articles 41 and 44 of this Regulation.

Article 49 U.K.

1. Without prejudice to the Protocol on the Privileges and Immunities of the European Communities, each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the implementing measures adopted pursuant to it in relation to medicinal products authorised through the procedures laid down in Directive 2001/83/EC and shall take all measures necessary for their implementation. The penalties shall be effective, proportionate and dissuasive.

Member States shall inform the Commission of these provisions by 26 October 2007. They shall notify any subsequent alterations as soon as possible.

2. Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.

[F1 3. The Commission may, in relation to medicinal products authorised in accordance with Regulation (EC) No 726/2004, impose, in accordance with the procedure laid down in Article 84a of that Regulation, financial penalties in the form of fines or periodic penalty payments for the failure to comply with the obligations set out in this Regulation that are listed in Annex II to Regulation (EC) No 726/2004.]

4. The Commission shall make public the names of anyone infringing the provisions of this Regulation or of any implementing measures adopted pursuant to it and the amounts of, and reasons for, the financial penalties imposed.

Textual Amendments

F1 Substituted by Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).

Article 50 U.K.

1. On the basis of a report from the Agency, and at least on an annual basis, the Commission shall make public a list of the companies and of the products that have benefited from any of the rewards and incentives in this Regulation and the companies that have failed to comply with any of the obligations in this Regulation. The Member States shall provide this information to the Agency.

2. By 26 January 2013, the Commission shall present to the European Parliament and the Council a general report on experience acquired as a result of the application of this Regulation. This shall include in particular a detailed inventory of all medicinal products authorised for paediatric use since its entry into force.

3. By 26 January 2017, the Commission shall present a report to the European Parliament and the Council on the experience acquired as a result of the application of Articles 36, 37 and 38. The report shall include an analysis of the economic impact of the rewards and incentives, together with an analysis of the estimated consequences for public health of this Regulation, with a view to proposing any necessary amendments.

4. Provided that there are sufficient data available to allow robust analyses to be made, the provisions of paragraph 3 shall be fulfilled at the same time as the provisions of paragraph 2.

Section 2 U.K. Standing committee

Article 51 U.K.

1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121 of Directive 2001/83/EC, hereinafter referred to as ‘the Committee’.

[F2 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.]

3. The Committee shall adopt its rules of procedure.

Textual Amendments

F2 Substituted by Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use (Text with EEA relevance).

CHAPTER 2 U.K. Amendments

Article 52 U.K.

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).’

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.’.

Article 53 U.K.

In Article 11 of Directive 2001/20/EC, the following paragraph shall be added:

‘4. By way of derogation from paragraph 1, the Agency shall make public part of the information on paediatric clinical trials entered in the European database in accordance with the provisions of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use(3).’

Article 54 U.K.

In Article 6 of Directive 2001/83/EC, the first subparagraph of paragraph 1 shall be replaced by the following:

‘1. No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or unless an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use(4).’

Article 55 U.K.

Regulation (EC) No 726/2004 is hereby amended as follows:

1)

Article 56(1) shall be replaced by the following:

‘1. The Agency shall comprise:

(a) the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use;

(b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use;

(c) the Committee on Orphan Medicinal Products;

(d) the Committee on Herbal Medicinal Products;

(e) the Paediatric Committee;

(f) a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them;

(g) an Executive Director, who shall exercise the responsibilities set out in Article 64;

(h) a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.’;

2)

in Article 57(1), the following point shall be added:

‘(t) taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use(5).’

3)

the following Article shall be inserted:

‘Article 73a

Decisions taken by the Agency under Regulation (EC) No 1901/2006 may form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty.’.

CHAPTER 3 U.K. Final provisions

Article 56 U.K.

The requirement laid down in Article 7(1) shall not apply to valid applications pending at the time of entry into force of this Regulation.

Article 57 U.K.

1. This Regulation shall enter into force on the thirtieth day following that of its publication in the Official Journal of the European Union.

2. Article 7 shall apply from 26 July 2008.

Article 8 shall apply from 26 January 2009.

Articles 30 and 31 shall apply from 26 July 2007.

(1)

OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).

(2)

OJ L 378, 27.12.2006, p. 1.’

(3)

OJ L 378, 27.12.2006, p. 1.’

(4)

OJ L 378, 27.12.2006, p. 1.’

(5)

OJ L 378, 27.12.2006, p. 1.’