Commission Regulation (EC) No 1234/2008Dangos y teitl llawn

SECTION 2 U.K. Amendments to the decision granting the marketing authorisation and implementation

Article 23 U.K. Amendments to the decision granting the marketing authorisation

[F1 1. Amendments to the decision granting the marketing authorisation resulting from the procedures laid down in Chapters II and IIa shall be made:

(a) in the case of major variations of type II, within two months following receipt of the information referred to in Article 11(1)(c) and Article 13e(a), provided that the documents necessary for the amendment of the marketing authorisation have been transmitted to the Member States concerned;

(b) in the other cases, within six months following receipt of the information referred to in Article 11(1)(c) and Article 13e(a), provided that the documents necessary for the amendment of the marketing authorisation have been transmi tted to the Member States concerned.]

[F2 1a. Amendments to the decision granting the marketing authorisation resulting from the procedures laid down in Chapter III shall be made:

(a) within two months following receipt of the information referred to in Article 17(1)(c) for the following variations:

(i)

variations related to the addition of a new therapeutic indication or to the modification of an existing one;

(ii)

variations related to the addition of a new contraindication;

(iii)

variations related to a change in posology;

(iv)

variations related to the addition of a non-food producing target species or the modification of an existing one for veterinary medicinal products;

(v)

variations concerning the replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine;

(vi)

variations related to changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;

(vii)

variations related to changes to the withdrawal period for a veterinary medicinal product;

(viii)

other type II variations that are intended to implement changes to the decision granting the marketing authorisation due to a significant public health concern or significant animal health or environmental concern in the case of veterinary medicinal products;

(b) within 12 months following receipt of the information referred to in Article 17(1)(c) in the other cases.

The Agency shall determine the variations referred to in point (a)(viii) and provide reasons for such determination.]

[F1 2. Where the decision granting a marketing authorisation is amended as a result of one of the procedures laid down in Chapters II, IIa, III and IV, the relevant authority or, in the case of centralised marketing authorisations, the Commission shall notify the amended decision without delay to the holder.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).

F2 Inserted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).

[F2 Article 23a U.K.

The statement indicating compliance with the agreed completed paediatric investigation plan provided for under Article 28(3) of Regulation (EC) No 1901/2006 shall be included within the technical dossier of the marketing authorisation.

The relevant authority shall provide the holder with a confirmation that the statement is included in the technical dossier within 30 days after the relevant assessment has been concluded.]

Textual Amendments

F2 Inserted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).

[F1 Article 24 U.K. Implementation of variations

1. Minor variations of type IA may be implemented any time before completion of the procedures laid down in Articles 8, 13a and 14.

Where a notification concerning one or several minor variations of type IA is rejected, the holder shall cease to apply the concerned variation(s) immediately after receipt of the information referred to in Articles 11(1)(a), 13e(a), and 17(1)(a).

2. Minor variations of type IB may only be implemented in the following cases:

(a) for variations submitted in accordance with the procedures laid down in Chapter II, after the competent authority of the reference Member State has informed the holder that it has accepted the notification pursuant to Article 9, or after the notification is deemed accepted pursuant to Article 9(2);

(b) for variations submitted in accordance with the procedures laid down in Chapter IIa, after the relevant authority has informed the holder that it has accepted the notification pursuant to Article 13b, or after the notification is deemed accepted pursuant to Article 13b(2);

(c) for variations submitted in accordance with the procedures laid down in Chapter III, after the Agency has informed the holder that its opinion referred to in Article 15 is favourable, or after that opinion is deemed favourable pursuant to Article 15(2);

(d) for variations submitted in accordance with the procedure laid down in Article 20, after the reference authority has informed the holder that its opinion is favourable.

3. Major variations of type II may only be implemented in the following cases:

(a) for variations submitted in accordance with the procedures laid down in Chapter II, 30 days after the competent authority of the reference Member State has informed the holder that it has accepted the variation pursuant to Article 10, under the condition that the documents necessary for the amendment to the marketing authorisation have been provided to the Member States concerned. Where an arbitration procedure has been initiated in accordance with Article 13, the holder shall not implement the variation until the arbitration procedure has concluded that the variation is accepted;

(b) for variations submitted in accordance with the procedures laid down in Chapter IIa, after the competent authority has informed the holder that it has accepted the variation pursuant to Article 13c;

(c) for variations submitted in accordance with the procedures laid down in Chapter III, after the Agency has informed the holder that its opinion referred to in Article 16 is favourable, unless the variation is one referred to in Article 23(1a)(a).

Variations referred to in Article 23(1a)(a) may only be implemented after the Commission has amended the decision granting the marketing authorisation and notified the holder thereof;

(d) for variations submitted in accordance with the procedure laid down in Article 20, 30 days after the reference authority has informed the holder that its opinion is favourable, under the condition that the documents necessary for the amendment to the marketing authorisation have been provided to the Member States concerned; unless an arbitration procedure has been initiated in accordance with Article 13, or unless the procedure concerns a variation to a centralised marketing authorisation as referred to in Article 23(1a)(a).

Where an arbitration procedure has been initiated in accordance with Article 13, or where the worksharing procedure concerns a variation to a centralised marketing authorisation as referred to in Article 23(1a)(a), the holder shall not implement the variation until the arbitration procedure has concluded that the variation is accepted, or until the Commission Decision amending the decision granting the marketing authorisation has been adopted.

4. An extension may only be implemented after the relevant authority or, in the case of extensions to a centralised marketing authorisation, the Commission has amended the decision granting the marketing authorisation and notified the holder accordingly.

5. Urgent safety restrictions and variations which are related to safety issues shall be implemented within a time frame agreed by the holder and the relevant authority and, in the case of a centralised marketing authorisation, the Agency.

By way of derogation from the first subparagraph, urgent safety restrictions and variations related to safety issues which concern marketing authorisations granted in accordance with Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC shall be implemented within a time frame agreed by the holder and the competent authority of the reference Member State, in consultation with the other relevant authorities.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).

[F2 Article 24a U.K. Application of national provisions on variations to purely national marketing authorisations

Member States that, in accordance with Article 23b(4) of Directive 2001/83/EC, may continue to apply their national provisions on variations to certain purely national marketing authorisations are listed in Annex VI to this Regulation.]

Textual Amendments

F2 Inserted by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance).