Legal provisions of COM(2012)52 - Amendment of Directive 2001/83/EC as regards pharmacovigilance - Main contents
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dossier | COM(2012)52 - Amendment of Directive 2001/83/EC as regards pharmacovigilance. |
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document | COM(2012)52 |
date | October 25, 2012 |
Article 1
(1) | in Article 23a, the second paragraph is replaced by the following: ‘If the product ceases to be placed on the market of a Member State, either temporarily or permanently, the marketing authorisation holder shall notify the competent authority of that Member State. Such notification shall, other than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. The marketing authorisation holder shall inform the competent authority of the reasons for such action in accordance with Article 123(2).’; |
(2) | Article 31 is amended as follows:
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(3) | in Article 34(3), the following subparagraph is added: ‘Where the scope of the procedure initiated under Article 31 includes medicinal products authorised in accordance with Regulation (EC) No 726/2004 pursuant to the third subparagraph of Article 31(2) of this Directive, the Commission shall, where necessary, adopt decisions to vary, suspend or revoke the marketing authorisations or to refuse the renewal of the marketing authorisations concerned.’; |
(4) | in Article 37, the words ‘Articles 35 and 36 shall apply’ are replaced by the words ‘Article 35 shall apply’; |
(5) | Article 63 is amended as follows:
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(6) | Article 85a is replaced by the following: ‘Article 85a In the case of wholesale distribution of medicinal products to third countries, Article 76 and point (c) of the first paragraph of Article 80 shall not apply. Moreover, points (b) and (ca) of the first paragraph of Article 80 shall not apply where a product is directly received from a third country but not imported. However, in that case wholesale distributors shall ensure that the medicinal products are obtained only from persons who are authorised or entitled to supply medicinal products in accordance with the applicable legal and administrative provisions of the third country concerned. Where wholesale distributors supply medicinal products to persons in third countries, they shall ensure that such supplies are only made to persons who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with the applicable legal and administrative provisions of the third country concerned. The requirements set out in Article 82 shall apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public.’; |
(7) | in Article 107i, paragraph 1 is replaced by the following: ‘1. A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, initiate the procedure provided for in this section by informing the other Member States, the Agency and the Commission where:
1a. A Member State or the Commission, as appropriate, shall, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, inform the other Member States, the Agency and the Commission where it considers that a new contraindication, a reduction in the recommended dose or a restriction to the indications of a medicinal product is necessary. The information shall outline the action considered and the reasons therefor. Any Member State or the Commission, as appropriate, shall, when urgent action is considered necessary, initiate the procedure provided for in this section in any of the cases referred to in this paragraph. Where the procedure provided for in this section is not initiated, for medicinal products authorised in accordance with the procedures laid down in Chapter 4 of Title III, the case shall be brought to the attention of the coordination group. Article 31 shall be applicable where the interests of the Union are involved. 1b. Where the procedure provided for in this section is initiated, the Agency shall verify whether the safety concern relates to medicinal products other than the one covered by the information, or whether it is common to all products belonging to the same range or therapeutic class. Where the medicinal product involved is authorised in more than one Member State, the Agency shall without undue delay inform the initiator of the procedure of the outcome of this verification, and the procedures laid down in Articles 107j and 107k shall apply. Otherwise, the safety concern shall be addressed by the Member State concerned. The Agency or the Member State, as applicable, shall make the information that the procedure has been initiated available to marketing authorisation holders.’; |
(8) | in Article 107i(2) the words ‘paragraph 1 of this Article’ are replaced by the words ‘paragraphs 1 and 1a of this Article’; |
(9) | in the second subparagraph of Article 107i(3) the words ‘in accordance with paragraph 1’ are replaced by the words ‘in accordance with paragraphs 1 and 1a’; |
(10) | in Article 107i(5) the words ‘in paragraph 1’ are replaced by the words ‘in paragraphs 1 and 1a’; |
(11) | in the first subparagraph of Article 107j(1) the words ‘in Article 107i(1)’ are replaced by the words ‘in paragraphs 1 and 1a of Article 107i’; |
(12) | Article 123 is amended as follows:
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Article 2
They shall apply those provisions from 28 October 2013.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.