The final version of Annex 21 to the EU-GMP Guidelines ("Importation of medicinal products") has been published in EudraLex Vol. 4. The draft was already published for comments in March 2020. Approximately 200 comments were received from 17 stakeholder organisations. The new Annex will come into operation on 21 August 2022. The Union legislation addresses all
Our CEO Ann McGee will be speaking at the Pharma and Brexit Conference - hosted by PDA Ireland and PDA United Kingdom. The event will focus on the impact, challenges and solutions for the pharmaceutical industry. Date - September 23rd, 2022 Venue - Crowne Plaza Hotel, Dublin Airport Time - 8:00 a.m. - 5:00 p.m. Register now on
FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers" In February 2022, the FDA has announced the availability of the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The proposed rule sets national licensing standards for both federal and
