New allergens
The Regulation (EU) 1545/2023 of the commission of 26 July 2023 which modifies the Reg. 1223/2009 (EC) of the European Parliament and of the Council...
The Regulation (EU) 1545/2023 of the commission of 26 July 2023 which modifies the Reg. 1223/2009 (EC) of the European Parliament and of the Council...
AIFA has published the attached document relating to the object"Following the requests for clarification received, information is provided in this...
3On 1/03/2023, the “Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 which amends regulation (EC) no. 1272/2008 as regards the...
Companies are advised that, from 1 April 2023, the rates contained in Annex 1 of the D.M. 6 December 2016, concerning "Update of current tariffs and...
Draft: WHO good manufacturing practices for excipients used in pharmaceutical 7 products.
Please note that all pharmaceutical companies must submit to the Italian Medicines Agency by and no later than 30 April 2023 the self-certification...
This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of...
Brussels, 6.1.2023 COM(2023) 10 final 2023/0005 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE...
Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral...