Legal provisions of COM(2011)632 - Amendment of Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use subject to medical prescription and as regards pharmacovigilance - Main contents
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| dossier | COM(2011)632 - Amendment of Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use ... |
|---|---|
| document | COM(2011)632  |
| date | October 11, 2011 |
Article 1
(1) In Article 13(4), the second subparagraph is replaced by the following:
"The holder shall also notify the Agency if the product ceases to be placed on the market of the Member State, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption in the placing on the market of the product. The holder shall inform the Agency of the reasons for such action in accordance with Article 14b of this Regulation."
(2) The following Article 14b is inserted:
"Article 14b
The marketing authorization holder shall notify the Agency forthwith of any action taken by him to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action. The marketing authorisation holder shall in particular declare if such action is linked to any of the grounds set out in Articles 116 and 117 of Directive 2001/83/EC. In such case, the Agency shall ensure that this information is brought to the attention of the Member States.(3) Article 20(8) is replaced by the following:
‘8. Where the procedure results from the evaluation of data relating to pharmacovigilance, the opinion of the Agency in accordance with paragraph 2 of this Article shall be adopted by the Committee for Medicinal Products for Human Use on the basis of a recommendation from the Pharmacovigilance Risk Assessment Committee and Article 107j(2) of Directive 2001/83/EC shall apply'.
(4) The following Articles 20a, 20b and 20c are inserted:
“Article 20a
1. Title VIIIa of Directive 2001/83/EC shall apply to medicinal products which are authorised under this Title and subject to medical prescription.
Article 20b
1. By way of derogation from Article 100g(1) of Directive 2001/83/EC, information referred to in Article 100b of that Directive concerning medicinal products for human use which have been authorised in accordance with this Regulation shall be subject to vetting by the Agency prior to its being made available .This shall be without prejudice to Article 100j of Directive 2001/83/EC relating to the monitoring by the Member States of the information made available.
2. For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be made available.
3. The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 60 days after receipt of the notification. If the Agency does not object within 60 days, the information shall be deemed accepted and may be published.
4. Where the marketing authorisation holder resubmits to the Agency a mock-up of the information to be made available following objections by the Agency in application of paragraph 3, if the Agency does not object within 30 days, the revised information shall be deemed accepted and may be published.
5. The Agency may if appropriate collaborate with Member States when it performs the tasks set out in this Article.
6. The submission of information to the Agency in accordance with paragraphs 1 to 4 shall be subject to a fee payable in accordance with Regulation (EC) No 297/95.”
Article 20c
1. By way of derogation from Article 100h(3) of Directive 2001/83/EC, the Agency shall be responsible for the prior vetting in accordance with Article 20b of this Regulation of information relating to medicinal products authorised in accordance with this Regulation which is contained in Internet websites registered with the national competent authorities of the Member States in accordance with Article 100h of Directive 2001/83/EC.2. Where a marketing authorisation holder intends to include information on a medicinal product authorised in accordance with this Regulation in an Internet website registered in accordance with Article 100h of Directive 2001/83/EC, it shall submit the information to the Agency for the application of Article 20b of this Regulation prior to it being made available, and inform the Agency of the Member State where the Internet website is intended to be or is registered. The Agency shall inform the concerned Member State of the outcome of the procedure of Article 20b.
3. By way of derogation from point (c) of Article 100h(4) of Directive 2001/83/EC, if a Member State has reasons for doubts as to whether the information approved in accordance with Article 20b of this Regulation made available on a registered Internet website complies with the requirements of Title VIIIa of Directive 2001/83/EC, it shall inform the Agency of the reasons for its doubts. The Member State concerned and the Agency shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Council Decision 75/320/EEC . Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States and the Agency shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
(5) Article 23 is replaced by the following:
"Article 23
1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring.That list shall include the names and active substances of:
(a) medicinal products authorised in the Union that contain a new active substance which, on 1 January 2011, was not contained in any medicinal product authorised in the Union;
(b) any biological medicinal product not covered by point (a) that was authorised after 1 January 2011;.
(c) medicinal products that are authorised pursuant to this Regulation subject to conditions referred to in points (c), (ca), (cb) and (cc) of Article 9(4), or in Articles 10a, Article 14(7) and (8) and in Article 21(2.;
(d) medicinal products that are authorised pursuant to Directive 2001/83/EC, subject to the conditions referred to in Articles 21a, 22, 22a and 104a of that Directive.
2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan.
3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 107c(5) of Directive 2001/83/EC.
In the cases referred to in points (c) and (d) of paragraph 1, the Agency shall remove a medicinal product from the list once the conditionshave been fulfilled.
.4. For medicinal products included in that list, the summary of product characteristics and the package leaflet shall include the statement “This medicinal product is subject to additional monitoring”. That statement shall be preceded by a black symbol which shall be selected by the Commission following a recommendation of the Pharmacovigilance Risk Assessment Committee by 2 January 2012, and shall be followed by an appropriate standardised explanatory sentence."
(6) In Article 26 the following paragraph 3 is added:
"3. The European medicines web-portal shall contain at least links to the following:
(a) the database on medicinal products referred to in point (l) of Article 57(1) of this Regulation,
(b) the Eudravigilance database referred to in Article 24(1) and point (d) of Article 57(1) of this Regulation,
(c) the database referred to in Article 111(6) of Directive 2001/83/EC,
(d) the Orphanet portal for rare diseases and orphan drugs,
(e) the Health Portal referred to in Decision 1350/2007/EC of the European Parliament and Council ."
(7) In Article 57(1), point (l) is replaced by the following:
"(l) creating a database on medicinal products, to be accessible to the general public and allowing searches in all official languages of the Union, and ensuring that it is updated, and managed independently of the commercial interests of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner.
(8) In Article 57(1), the following point (u) is added:
“(u) on reviewing information to the general public on medicinal products for human use subject to medical prescription.”
(9) In Article 57(2), the first subparagraph is replaced by the following:
"2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include any medicinal product placed on the market within the Union. That database shall be actively promoted to European Union citizens".
Article 2
2. It shall apply from [OJ: insert date of entry into force] with the exception of Article 1 (4) and (8) which shall apply from [OJ: insert date of publication + 4 years].
This Regulation shall be binding in its entirety and directly applicable in all Member States.