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Importation Services
IMPORT AND SUPPLY CHAIN MANAGEMENT
For all the Marketing Authorisation Holders (MAHs) of medicinal products manufactured outside the EU/EEA territory, that wish to introduce it into EU market, there is a need to have the medicinal product importer responsible for batch certification. Medicinal products import to EU countries is one of the core services provided by Hub Net Scientific Pharma in terms of supporting the presence of medical products from third countries (outside the EU / EEA) on the European market. We provide importation services comprehensively and ensure professional verification of compliance with EU legal regulations and GMP/GDP.
The requirements applicable when importing medicinal products to the EU are described in the
EU GMP guideline and summarized in new Annex 21 to the EU GMP, which came into force in August 2022. Following the Annex 21, within the importation process, we can distinguish the following places linked to their corresponding activities:
- the site of physical importation with the primary role of receipting the imported product, the site of batch certification or - for bulk or intermediate products that are furth processed - QP confirmation.
Given their specific importation responsibilities the above-listed sites are required to hold relevant Manufacturing & Import Authorisation Licence (MIA Licence) and appropriate GMP-compliant pharmaceutical quality system implemented considering the scope of the activities carried out in place.
At Hub Net Scientific Pharma we fulfil this requirement and proclaim as a qualified partner employing highly experienced specialists who can comprehensively carry out the import process. Hub Net Hub Net Scientific Pharma is a holder of its own MIA licence. If needed, we can also rely on the MIA of our proven, long-term partners providing one-stop-shop importation services for all importation activities needed
THE EU IMPORTER - MIA LICENCE AND GMP-COMPLIANT PHARMACEUTICAL QUALITY SYSTEM
Hub Net Scientific Pharma experts have wide experience in managing medicinal products importation. We work in accordance with the Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). We provide importation services extensively, taking care of all the stages including: worldwide transport organisation, storage, distribution and supply chain management. A substantial part of our activity is batch control studies in contract quality laboratories located all over the EU.
We do have extensive knowledge and experience in the field of: transportation (air, road, sea and rail transport) in partnership with reliable shipping companies,
custom clearance in cooperation with Custom Agencies (in manufacturing and destination countries), storage conditions assessment.
product storage at the site of physical importation, complaints and quality defects management, serialization alerts supervision, commissioning and supervising of quality control studies,
management of analytical methods transfers to laboratories located in the EU
Hub Net Scientific Pharma EXPERTS HAVE EXPERIENCE IN PROVIDING MANUFACTURING AND IMPORTATION
SERVICES WORLDWIDE
Hub Net Scientific Pharma provides services to small, medium and large pharmaceutical companies located worldwide. Our experts have experience in manufacturing and importation activities, serving Clients from third countries manufacturing their medicinal products in Asia and South America as well as in the US, and in European countries beyond the EU territory. Our advantage comes from in-depth knowledge of EU law and national specific legal requirements, procedures and expectations of the registration agencies in EU countries, which is the key for success in both importation of products and the overall pharmaceutical regulatory support and projects management.
