Efficient customs clearance and import solutions for your pharmaceuticals
Fast, secure, stress-free – with SK Pharma Logistics, clearing customs and importing your medicines runs like clockwork. We are familiar with the challenges associated with customs clearance and know exactly what the issues are.
Benefit from individually tailored solutions ensuring that your pharmaceuticals smoothly cross borders and with full compliance.
Our expertise in pharmaceutical customs clearance & documentation
Planning and organisation
Import and export of medicinal products
Optimised processes for the secure import and export of pharmaceuticals. Fast, reliable processing in close co-operation with customs authorities.
Documentation for customs clearance
Careful preparation and timely submission of all customs documents to avoid delays and speed up the process.
Compliance with international customs regulations
Support with the application and review of import permits and licenses – e.g., according to AMG, TAMG, or MDR – especially for medicinal products and products subject to authorization.
Quality assurance and compliance
Regulatory requirements and compliance
Regular audits and inspections to ensure the highest quality standards in the transport and storage process.
Specialised customs clearance for pharmaceutical products
Maßgeschneiderte Lösungen, die die spezifischen Anforderungen der Pharmaindustrie erfüllen, um eine sichere und regelkonforme Zollabwicklung zu gewährleisten.
Efficient documentation and administration
Automated documentation processes and continuous information availability to promote transparency and trust.
Good reasons for customs clearance and importing your pharmaceuticals with SK Pharma
Cost-efficiency
Reduction of import costs through optimised processes and more favourable conditions for customs clearance.
Regulatory expertise
Ensuring compliance with international and local regulations and minimising delays or penalties.
Time savings
Efficient customs clearance shortens delivery times and accelerates the market launch of products.
A more secure supply chain
Improved transparency and security through proper documentation and handling reduces losses and transport risks.
Risk minimisation
Reduction of risks such as delays, irregularities in customs clearance and legal challenges.
Market access
Support in accessing new markets by navigating complex customs regulations and trade barriers.
SK Pharma – your logistics professional for import and customs clearance
With over 20 years of experience in pharmaceutical and healthcare logistics, we bring you all the expertise needed for customs clearance and import handling, a strong global network of transport partners and flexible storage solutions – including capacity for over 80,000 pallets.
Our team ensures that your requirements are met with first-class service and reliable project management, supported by innovative IT and logistics systems. We also offer customised services such as packaging, serialisation and quality control, all perfectly tailored to your needs.
Flexible solutions beyond import processing
Our flexible modular system enables efficient customs and import processing as well as the option to combine additional services individually: From customer service and order processing to specialized packaging, kitting and serialization.
We offer customised solutions that guarantee product protection, traceability and efficiency throughout the entire import process. Rely on SK Pharma Logistics to fulfil your requirements precisely and optimise your processes.
Certified for top quality and safety
SK Pharma Logistics offers GDP-certified processes that fulfil the requirements of the German Medicinal Products Act (AMG), Veterinary Medicinal Products Act (TAMG), Therapeutic Products Act (HMG) and Good Distribution Practice (GDP). This is how we ensure the safe and compliant transport of your pharmaceutical products. You can rely on our certified expertise in pharmaceutical transport logistics.
Certificates
GDP certificate Bielefeld
GMP certificate for human medicine
GMP certificate for veterinary medicine
Manufacturing authorisation for medicinal products for human use
Manufacturing authorisation for veterinary medicine
Wholesale authorisation for medicinal products for human use
GDP Certificate Veterinary Medicinal Products
Wholesale Distribution Authorisation Veterinary Medicinal Products
Manufacturer’s Authorisation Veterinary Medicinal Products
Wholesale Distribution Authorisation
Manufacturer’s Authorisation
Manufacturer’s Authorisation Veterinary Medicinal Products
FAQ on the import of medicinal products
What does import processing in pharmaceutical logistics entail?
Import processing encompasses all the necessary medicinal products and customs law measures for placing medicinal products on the market in Germany. This specifically includes the import permit according to § 72 AMG, a product-related certificate according to § 72a para. 1 sentence 1 no. 2 AMG, as well as a certificate according to § 73 para. 6 AMG, which is required for customs clearance.
Does SK Pharma support the creation of import documents?
Yes, we hold a valid import permit according to § 72 AMG and can, as part of this, apply for and provide the required import certificates. This actively supports the entire documentation process.
Does SK Pharma also handle customs clearance?
Yes, we handle pharmaceutical customs clearance by applying for the necessary certificate according to § 73 para. 6 AMG, which is mandatory for release by customs.
Wie wird die Einhaltung der GMP-Richtlinien beim ImpoHow is compliance with GMP guidelines ensured during import?rt sichergestellt?
Imported medicinal products may only be placed on the market after market release by a Qualified Person (QP) in accordance with EU regulations. SK Pharma ensures that this release is carried out by a correspondingly qualified EU-QP and that compliance with GMP guidelines is guaranteed.
Can temperature-controlled products also be imported?
Yes, we can organize the processing of temperature-controlled medicinal product imports. In doing so, we work with experienced and qualified partners to ensure that the prescribed temperature ranges are reliably maintained throughout the entire supply chain.
Does SK Pharma also support the import of narcotic drugs?
Yes, we can provide support with the import of narcotic drugs within the framework of the Narcotics Foreign Trade Ordinance (BtMAHV) and apply for the required import certificates from the Federal Opium Agency (BOpSt).
Which countries does SK Pharma cover in import processing?
In principle, imports from all countries can be processed, provided that the manufacturer in the exporting country holds a valid EU GMP certificate. This is a prerequisite for approval by the competent authorities.
How long does import processing take?
The duration of import processing depends significantly on the processing time of the competent authority. The issuance of the necessary import certificates can take up to one month. Early planning is therefore recommended.
Does SK Pharma support compliance with country-specific requirements?
For imports to Germany, only the requirements of the German Medicines Act (AMG) and the EU GMP guidelines apply. Country-specific import requirements from other states therefore do not need to be taken into account.
Do you have any questions?
No problem – we are here for you and will be happy to help!