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 2001/83/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.