Chapter III, Article 17, Paragraph 2. · Regulation (EU) 2022/123

Contents

2.Where a medicinal product of relevance to the public health emergency receives a marketing authorisation, the Agency shall publish, in particular:

(a)the product information with details of the conditions of use at the time of the marketing authorisation;

(b)the European Public Assessment Reports as soon as possible and, where possible, within seven days of the marketing authorisation;

(c)the clinical data submitted to the Agency in support of the application, where possible within two months of the marketing authorisation by the Commission;

(d)the entire risk management plan referred to in Article 1, point 28c, of Directive 2001/83/EC, and any updated versions thereof.

For the purposes of the first subparagraph, point (c), the Agency shall anonymise all personal data and redact commercially confidential information.

Defined terms · 9

Show every defined term

demand
means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need;
developer
means any legal or natural person seeking to generate scientific data with regard to the quality, safety and efficacy of a medicinal product as part of the development of that product.
major event
means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State, which concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin, or a serious incident that can affect the supply of or demand for medicinal products, or quality, safety or efficacy of medicinal products, which may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection;
medical device
means a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745 or an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746, and includes accessories for such devices within the meaning of Article 2, point (2), of Regulation (EU) 2017/745, and Article 2, point (4), of Regulation (EU) 2017/746, respectively;
medicinal product
means a medicinal product as defined in Article 1, point (2), of Directive 2001/83/EC;
public health emergency
means a situation of public health emergency recognised by the Commission in accordance with Article 12(1) of Decision No 1082/2013/EU;
shortage
means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet demand for that medicinal product or medical device at a national level, whatever the cause;
supply
means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;
veterinary medicinal product
means a veterinary medicinal product as defined in Article 4, point (1), of Regulation (EU) 2019/6 of the European Parliament and the Council;