Reference:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 Article 26

Document information
Reference	EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22
Validity area	EU
Scope(s)	NIS
Document name	Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use
Version / Revision	28-Jan-22
Status	Current
Document type	Legal act
Language(s)	EN
Description	Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 1 — Unit 1.5.4
Scope	NIS
Document part	Article 26
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	EudraCT, Publication, Post-authorisation safety study, EMA, Medicinal product
Comment	EU medicines web portal (EU PAS Register): setup and management by Agency and Member States

Content

Article 26

1. The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a European medicines web-portal [EU PAS Register] for the dissemination of information on medicinal products authorised in the Union. By means of that portal, the Agency shall make public at least the following:

(a) the names of members of the Committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the members of the coordination group, together with their professional qualifications and with the declarations referred to in Article 63(2) of this Regulation;

(b) agendas and minutes from each meeting of the Committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and of the coordination group as regards pharmacovigilance activities;

(c) a summary of the risk management plans for medicinal products authorised in accordance with this Regulation;

(d) the list of medicinal products referred to in Article 23 of this Regulation;

(e) a list of the locations in the Union where pharmacovigilance system master files are kept and contact information for pharmacovigilance enquiries, for all medicinal products authorised in the Union;

(f) information about how to report to national competent authorities suspected adverse reactions to medicinal products and the standard structured forms referred to in Article 25 for their web-based reporting by patients and healthcare professionals, including links to national websites;

(g) Union reference dates and frequency of submission of periodic safety update reports established in accordance with Article 107c of Directive 2001/83/EC;

(h) protocols and public abstracts of results of the post-authorisation safety studies referred to in Articles 107n and 107p of Directive 2001/83/EC;

(i) the initiation of the procedure provided for in Articles 107i to 107k of Directive 2001/83/EC, the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings;

(j) conclusions of assessments, recommendations, opinions, approvals and decisions taken by the Committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and by the coordination group, the national competent authorities and the Commission in the framework of the procedures of Articles 28, 28a and 28b of this Regulation and of sections 2 and 3 of Chapter 3 and Chapter 4 of Title IX of Directive 2001/83/EC.

2. Before the launch of this portal, and during subsequent reviews, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals and industry representatives.