News and Educations

Notice to applicants for submitting variations to the medicine’s documentation pursuant to the referral procedure for amoxicillin containing medicinal products


The European Commission adopted on 20 August 2015 Commission implementing Decision concerning, in the framework of Article 30 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisation for "Amoxil and associated names”, medicinal products for human use which contain the active substance "amoxicillin”(Procedure No EMEA/H/A-30/1372). Detailed information on this Decision is accessible on the European Commission website.

HALMED is inviting all marketing authorisation holders for amoxicillin-containing medicines in the Republic of Croatia, that are not listed in Annex I of Commission's Decision, to submit in the shortest time the application for variation to the medicine’s documentation.