Pharmaceutical exports to the UK, ready for MHRA authorisation

Yes. Progene Pharma manufactures generic medicines in an EU-GMP and WHO-GMP certified facility and supplies them to marketing authorisation holders, importers, wholesalers and tender suppliers in the UK.

Yes. Progene Pharma prepares the manufacturing and quality documents an application needs: the CTD dossier, stability data, the GMP certificate and the manufacturing details. Your British company files the application, and we answer MHRA's questions with you.

Yes. The authorisation is held by a company established in the UK, usually the importer or distributor. Check the current requirements with the MHRA.

No. Since Brexit the UK has run its own system, so a medicine needs a UK authorisation. Documents prepared for an EU dossier can often be reused, and the MHRA also offers a route that relies on approval by a recognised regulator. We prepare the documents to fit both. Check the current requirements with the MHRA.

The usual set is the CTD dossier, stability data at European conditions, the manufacturer's GMP certificate and manufacturing details, bioequivalence data for most generics, the active substance master file details and product information. MHRA updates its requirements from time to time, so confirm the current list with MHRA or your regulatory consultant. We tell you what we can provide with your quotation.

A Qualified Person at a UK site with the right importation authorisation tests and certifies each batch before it goes on sale. Your importer normally holds that authorisation, and we supply the batch documents the Qualified Person needs.

It is the published list of what the NHS reimburses pharmacies for dispensing generics. It keeps generic prices competitive, so a manufacturer needs a dependable supply chain and a competitive price.

Northern Ireland follows some EU rules for medicines under the post-Brexit arrangements, so supply there can need extra steps. Tell us where you plan to sell and we will confirm what we can provide.

English text following the MHRA product information requirements, the authorisation number, batch number, expiry date, storage conditions, Braille on the carton and the safety features UK prescription medicines carry. We prepare the artwork to match your authorisation and you approve a proof before printing.

Yes. Progene Pharma tests products at 25 °C and 60% relative humidity (climate Zone II), the condition European authorities ask for, and packs them in moisture-resistant blisters or bottles, so the shelf life on the pack is valid.

Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for. Tell us the tender requirements and we will confirm what we can provide.

Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Felixstowe, Southampton or London Gateway, or by air to London for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.

It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.