OTC Medicines Archives | Page 17 of 48 | PAGB

Membership

We are the only trade association representing the interests of manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK.

Learn more

MHRA Marketing Authorisations Granted 1 to 14 January 2024

MHRA granted one OTC license in January 2024.

EMA HMPC Questions & Answers on Quality of Herbal Medicinal Products – Revision 7

EMA Committee on Herbal Medicinal Products (HMPC) has published the revised questions & answers on quality of herbal medicinal products/traditional herbal medicinal products.

CMDh January 2024 Meeting – Report

The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 23-25 January.

HMA Meetings – September and December 2023

Heads of Medicines Agencies (HMA) has published the minutes of its 113th and 114th meetings.

EMA PRAC Work Plan 2024

The European Medicines Agency (EMA) has published the Pharmacovigilance Risk Assessment Committee (PRAC) Work Plan 2024 which was adopted by the Committee on 26 January 2024.

EU 101st Pharmaceutical Committee Meeting – 23 November 2023

The summary record of the 101st meeting of the Pharmaceutical Committee that took place on 23 November 2023 has been published.

MHRA Performance Data for Assessment of Clinical Trials and Established Medicines

MHRA has published MHRA performance metrics for clinical trials and established medicines assessment.

EMA Q&A Document on Article 5(3) of Regulation (EC) 726/2004 – Nitrosamine Impurities in Medicines

EMA has updated the Q&A document related to nitrosamine impurities in medicinal products.

Border Target Operating Model (BTOM) material

The Cabinet Office has published useful material on BTOM.

MHRA Launches New Fees Calculator

MHRA has developed a fees calculator to help companies calculate the fees they will be charged when making an initial or a variation application for a medicinal product.

NHS Standard Contract 2024/25 Consultation

NHSE has published the draft 2024/25 NHS Standard Contract for consultation. The consultation paper describes the main, material changes being proposed in the Contracts. NHSE welcome comments from stakeholders and Industry on the proposals.

MHRA Publishes Marketing Authorisations Granted 15 December to 31 December 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has published the list of marketing authorisations granted during 15 - 31 December 2023, which includes four GSL licences.