GMP Inspection Representation in Croatia

“Quality is a way of managing an organization.” | K. Ishikawa

GMP Representation Services

SUPERA KVALITETA provides GMP inspection representation services for companies located outside the European Union.

We support manufacturers in submitting applications for Good Manufacturing Practice (GMP) inspections to the Croatian Agency for Medicinal Products and Medical Devices (HALMED).

Our services also include communication with HALMED throughout the application and inspection process.

GMP Inspections in the European Union

Manufacturers of medicinal products and active pharmaceutical ingredients (APIs) are subject to regulatory oversight in the European Union.

Competent authorities monitor compliance with Good Manufacturing Practice (GMP) requirements.

Each EU Member State has its own competent authorities responsible for GMP inspections. The location of the manufacturing site and the applicable regulatory procedure determine which authority is responsible.

GMP requirements for medicinal products are established through European legislation. Detailed guidance is provided in the EU GMP Guide and its Annexes.

GMP Inspections for Non-EU Manufacturers

Manufacturers located outside the EU must consider the regulatory requirements applicable to their products.

For medicinal products imported into the EU, an appropriate manufacturing and importation authorisation is generally required.

Manufacturing sites in third countries may also be subject to inspections by competent EU authorities.

The need for an inspection depends on the applicable regulatory framework and the circumstances of the manufacturing site.

A GMP inspection may be requested in connection with a marketing authorisation application or an existing marketing authorisation.

GMP Inspection Applications

An EU importer or Marketing Authorisation Holder (MAH) may request a GMP inspection of a manufacturing site located in a third country.

In certain circumstances, it may also be possible to request an inspection voluntarily.

Companies should contact the relevant competent authority to determine the applicable procedure and inspection requirements.

Communication and Representation Before HALMED

Companies located outside the EU may require regulatory support when preparing an application for a GMP inspection.

SUPERA KVALITETA provides assistance with the application process and communication with HALMED in Zagreb, Croatia.

Our services help non-EU manufacturers navigate the relevant administrative procedures and coordinate communication with the competent authority.