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Regulatory Affairs

Elemental Impurities for Safe Veterinary Medicinal Products, one year after the due date

Discover the ongoing challenges faced by Veterinary Marketing Authorization Holders and Manufacturers in managing elemental impurities in veterinary.

Regulatory Affairs

What is SPOR?

Learn about SPOR (Substance, Product, Organization and Referential), the European Medicines Agency's requirement for implementing ISO IDMP standards..

Regulatory Affairs

Are your Veterinary Medicinal product information already compliant with QRD Version 9.0? Be prepared to submit the variations

The EMA has introduced the QRD Template Version 9.0 for product information used by the MAH. The updated template must be adopted by January 2027.

Regulatory Affairs

Environmental Risk Assessment of Medical Products for Human Use: Comparison between EMA & FDA Requests

The important role of Environmental risk assessment (ERA) before applying for marketing authorization in Europe and in the United States.

Regulatory Affairs

Prevention and management of human medicinal product shortages in compliance with the recent EMA guideline on good practices for industry

2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.

Regulatory Affairs

Reform of the pharmaceutical sector by the EU Commission

At the end of April 2023, the EU Commission announced the largest reform of the pharmaceutical sector in over 20 years. Why is this happening right.

Regulatory Affairs

European Medicines Agency Guidelines for the Environmental Risk Assessment of Veterinary Medicinal Products (VMPs)

The European Medicines Agency (EMA) has issued guidelines for the environmental risk/impact assessment (ERA or EIA) of veterinary medicinal products.

Regulatory Affairs

Are your products correctly classified under Article 34, Reg. (EU) 2019/6?

The Committee for Veterinary Medicinal Products has released a new guideline on the prescription status of veterinary medicinal products.

Regulatory Affairs

Elemental Impurities in Veterinary Medicinal Product

In January 2023, the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products will enter into.

Regulatory Affairs

Are you ready? Have you implemented EU ISO IDMP standards for medicinal products?

Are you ready to implement the EU ISO IDMP standards for medicinal products? Discover with us how to safely move to the new standards