The Predicted Impact of the ISO IDMP Standards Implementation Process Carried Out by the European Medicines Agency
Current Background in the EU The IDMP (Identification of Medicinal Products) is a general term by which the 5 ISO data standards are referenced: ISO 11615 (regulated medicinal product information), ISO 11616 (regulated pharmaceutical product information), ISO 11238...
Falsified Medicines Directive Implementation – Marketing Authorization Holder Perspective
Falsified Medicines Directive (FMD) 2011/62/EU which aims to increase the security of manufacturing and delivery of medicines across Europe as well as protect patients and prevent falsified medicines from entering the supply chain has come in force Feb 9th, 2019. With...
Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)
On 29th March 2017 United Kingdom (UK) submitted the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (EU). This means that the United Kingdom will become a ‘third country’ from 30th March 2019. Even...
Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?
Compliance with high-quality standards is a non-negotiable performance parameter in the Pharmaceutical and Medical Device industries. In 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485...
