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The EMA Secretariat gave an update on the ISO IDMP standards on the identification of medicinal products covering both authorised medicinal products and investigational medicinal products and the current work of the EU task force. The PRAC delegates were invited to send any questions they may have on this topic to relevant EMA colleagues. 13. Any other business 13.1. EMA move in 2014 to new building The PRAC received a status update from the EMA secretariat on the preparation of the EMA’s move to a new building in July 2014. 13.2. EMA reorganisation New organisational model: changes in the operation of processing Type II variations The EMA secretariat presented a proposal for changes in the assessment process for type II variations, including a proposed function for a rolling timetable to be applied to processing such procedures at the level of the EMA and National Competent Authorities. The EMA Secretariat also presented a draft new template for the assessment report to be applied to all type II variations (quality and (non-)clinical). The PRAC delegates were invited to send comments by 15 July 2014. EMA secretariat also launched a call for PRAC representatives to participate in revision of current process for evaluation of initial marketing authorisation application. The PRAC delegates were invited to express their interest in participating in the review process. 13.3. Procedural Advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology Proposed revision to existing procedural advice document At the organisational matters teleconference held on 26 June 2014, the EMA secretariat presented a proposal to amend the existing procedural advice to cover the principles, objective criteria and methodologies for rapporteurship appointments as they relate to the PRAC. The PRAC delegates were invited to send comments by 4 July 2014. In this context, the EMA secretariat also presented a proposal for the appointment of Member States for PSUR single assessment for substances in Nationally Approved Products only. The PRAC delegates were invited to send comments by 18 July 2014. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 48/75
14. ANNEX I Risk Management Plans Medicines in the pre-authorisation phase As per agreed criteria, the PRAC endorsed without further plenary discussion the conclusions of the Rapporteur on the assessment of the RMP for the below mentioned medicines. 14.1.1. Clopidogrel, acetylsalicylic acid Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002272 Intended indication: Prevention of atherothrombotic events 14.1.2. Daclatasvir Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003768 Intended indication: Treatment of chronic hepatitis C virus (HCV) 14.1.3. Darunavir, cobicistat Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002819 Intended indication: Treatment of patients with human immunodeficiency virus (HIV-1) in: 1) antiretroviral therapy (ART) naïve adults; 2) Antiretroviral therapy (ART)-experienced adults with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l 14.1.4. Edoxaban Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002629 Intended indication: Prevention of stroke and systemic embolism and treatment of venous thromboembolism 14.1.5. Flutemetamol F-18 Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002557 Intended indication: Visual detection of amyloid-beta neuritic plaques in the brains 14.1.6. Lutetium, isotope of mass 177 Evaluation of an RMP in the context of an initial marketing authorisation application procedure Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 49/75
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