![]() When the marketing cessation or withdrawal is due to reasons listed in Articles 116 and 117 (e.g. The MAH should specify the reasons for such action and particularly if this is solely based on a commercial decision or related to any of the reasons listed in Articles 116 and 117 of Directive 2001/83/EC (e.g. This also includes the withdrawal of a medicinal product from the EU market, or any decision to withdraw or suspend the marketing authorisation or not to apply for the renewal of a marketing authorisation. MAHs shall also report to the Agency any marketing cessation (temporary/permanent) of their medicinal product per presentation and per Member State. ![]() ![]() Of note, for centrally authorised medicinal products, presentation corresponds to pack-size. The actual marketing of a centrally-authorised medicinal product (CAP) shall be reported to the Agency per presentation and per Member State (see question What is the meaning of “actual marketing” / “placing on the market”? ).What is the aim of monitoring the marketing status of medicinal products? Rev. The date of marketing cessation shall be the date of the last release into the distribution chain.ģ. In accordance with Article 13(4) of Regulation (EC) No 726/2004, Marketing Authorisation Holders are required to inform EMA if their centrally-authorised product ceases to be placed on the market of a Member State, either temporarily or permanently.īy analogy to the placing on the market, the “cessation of placing on the market” or “marketing cessation” is defined in the general principles outlined in the Chapter 1 of volume 2A of the Notice to Applicants as the “cessation of release into the distribution chain” with the consequence that the concerned product may no longer be available for the supply to the patients. What is the meaning of “cessation of placing on the market”? Rev. Chapter 1 (section 2.4.2), The Rules governing Medicinal Products in the European Union, Notice to Applicants, Volume 2AĢ.Article 23a of Directive 2001/83/EC, as amended.This also applies to the placing on the market following a marketing cessation.įor centrally-authorised medicinal products “marketed” means that at least one presentation of the medicinal product is at least marketed in one Member State of the Union. out of the direct control of the Marketing Authorisation Holder. The actual marketing corresponds to the “placing on the market” which is defined in Chapter 1 of volume 2A of the Notice to Applicants as the date of release into the distribution chain i.e.In accordance with Article 13(4) of Regulation (EC) No 726/2004, Marketing Authorisation Holders are required to inform EMA of the date(s) of actual marketing of their centrally-authorised product on the Union Market.
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