The MHRA, on behalf of the Department of Health, issues export certificates on request to assist exporters of medicinal products to satisfy the import requirements of other countries. The certificates issued by MHRA indicate whether the product or manufacturer to which the certificate applies has met statutory requirements. Where necessary, the format of certificates complies with that specified by international authorities, for example, the World Health Organisation (WHO) and the MHRA will not deviate from the agreed format. Details about charges for issuing certificates, further details about the certificates available and forms to make applications are available in this section.
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While the issuing of certificates is managed by MHRA, the requirement for having a certificate is not - it is determined by the importing country. As such, the MHRA has no legislative authority over the requirements of the importing country and cannot specify whether or not certificates are needed. If there is doubt about whether or not the regulatory authorities in an importing country may require an export certificate the embassy of the country for which the importation is intended should be contacted. Foreign consulate contact details can be accessed on the Foreign Office website.
Guidance published on UK exporting of medicines - 13 November 2009
Guidance helping pharmaceutical manufacturers and distributors to meet their obligations regarding the supply of medicines has been jointly published by nine organisations including the MHRA. The new guidance aims to reduce future problems with the export of medicines for profit by setting out the key legal and ethical obligations for manufacturers, wholesalers, NHS Trusts, registered pharmacies and dispensing doctors in relation to the supply and trading of medicines.
Information on types of export certificates
The MHRA issues four different types of export certificates, two of which comply with the format established by the WHO and reflect UK participation in the WHO scheme. Each type of certificate is country specific, naming one individual country - the EU is not acceptable as a one-country unit. The fee charged is the same for each type of certificate but varies dependant on the service level (24-hour or five-day turnaround) requested and the number of original copies required. Details about charges for issuing certificates can be found in our licensing fees section. The certificates that can be supplied are:
Certificate of a pharmaceutical product (CPP). This certificate complies with the format specified by WHO. The certificate will provide details about a single named medicinal product which may be licensed or unlicensed in the UK. It provides details about the product and its manufacture including (but not limited to) the marketing authorisation (MA) holder, the active ingredients and excipients, the manufacturing and packaging sites and whether or not the product is placed on the market in the UK. CPPs for licensed products are generally but not exclusively, applied for by the marketing authorisation holder. For the MHRA to issue a certificate to an applicant other than the marketing authorisation holder written permission from the marketing authorisation holder will be required before the application can be accepted.
Certificate of licensing status (CLS). This certificate complies with the format specified by the WHO. It is intended for use by importing agents who are required to screen bids made in response to an international tender and can apply to licensed or unlicensed products. It provides less information than the CPP and can include a maximum of ten products per certificate.
Certificate of manufacturing status (CMS) does not provide any product specific information, but it confirms whether named sites meet Good Manufacturing Practice (GMP) requirements on a specified manufacturing licence number. All or any of the sites named on the manufacturing licence may be listed on the certificate.
Certificate for the importation of a pharmaceutical constituent (CPC) is available for a named constituent of a medicinal product.
The MHRA will only issue certificates for unlicensed medicinal products that are manufactured in the UK on a site holding a manufacturer's licence appropriate to the dosage form of the product for which the certificate applies. If an application is made for a certificate for a medicinal product that is not manufactured in the UK it will only be issued if the product has a UK (not EMA) product licence. It is not possible to issue a certificate for unlicensed products manufactured outside the UK.
For information on products with a European licence number contact:
The European Medicines Agency (EMA) (external link)
7 Westferry Circus, Canary Wharf, London E14 4HB
Tel: 020 7418 8400
Export certificate application forms
Information for completion of export certificate application forms
The certificate of a pharmaceutical product (CPP) requires the most detailed information. All forms ask for date of application, your reference, your name and business name and address, invoice details if different from the applicant's, name of importing country, standard or urgent service, language and number of copies required.
The CPP is usually applied for by the marketing authorisation holder. This is not mandatory but if you are not the MA holder you must submit authorisation from the MA holder permitting you to export on their behalf. It must be on headed paper, should stipulate the product or give open authorisation for all products. It can specify a date range within which applications are acceptable or can be open ended.
The MA/PL number must be quoted along with the name and dosage form of the product. A certificate can only state one strength. A product may be registered under several names but only one name can be quoted on the certificate. However a different name may be quoted in the importing country. If the name in the importing country is the same as the registered name it is not necessary to complete this box on the application form (1.8).
The list of actives and excipients and their full quantitative formulation must be as detailed against the MA/PL number. Any variations to the MHRA database will be queried and it may be necessary to submit a copy of the licence or MHRA variation letter to support any differences. It is optional whether the amounts of the excipients appear on the certificate but they must be quoted on the application form.
The status of the MA holder can only be a, b or c. The fourth option, d, is only available to applicants of unlicensed products. The MA holder is considered to be ultimately responsible even if they are not involved in the manufacture or packaging processes. If option a applies the applicant should complete section 3.4 but the name and address will not be stated again on the certificate. If option b applies and there is more than one manufacturer the applicant can opt whether to have one or more manufacturers listed. If there are more packagers the applicant can choose which to include. If option c applies and there are multiple manufacturers or packagers the applicant can opt which ones to include on the certificate. The applicant can also opt whether to name the manufacturing licence holder provided it is a UK licence holder. Overseas licence holders cannot be quoted.
The unlicensed CPP is very similar but without the requirements of a MA/PL number and MA holder details. Also the manufacturing site must be located in the UK and hold a current manufacturer's licence.
The certificate of manufacturing status requires the manufacturing licence holder number - this must be a UK licence holder, an overseas licence number is not acceptable. If more than one site is included on the licence the applicant can select which or all of the sites to include on the certificate.
The certificate of licensing status is limited to ten products per certificate and is country specific. Details of the product name, dosage form, active ingredients and amounts should all be quoted in accordance with their product licence (if applicable) and these details will be checked against the MHRA database. Any differences will be queried and will need to be verified.
The certificate for the importation of a pharmaceutical constituent is country and ingredient specific. The specific active or excipient must be must be included as an ingredient in a current licensed medicinal product or the material must be included in a national or international pharmacopoeia, the specification being equivalent to that monograph. A schedule and certificate of analysis will be attached to each certificate.
Contacts for further information
For further information on this part of our site, please contact our Export Section, 5 Yellow, MHRA, 151 Buckingham Palace Road, telephone 020 3080 6593 or email email@example.com
For veterinary products
Veterinary Medicines Directorate, Central Veterinary Laboratories (external link)
Tel: 01932 336911
For food products
DEFRA (food, retail and catering)
Tel: 020 7238 3175
Department of Trade & Industry, Export Control Organisation
4 Abbey Orchard Street
Tel: 020 7215 8070
If you are uncertain if the product is medicinal or not contact the Borderline Section at the MHRA for guidance:
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
Tel: 020 3080 6759
If it is a medicinal product and it is, or does contain, a controlled substance:
Home Office Customer Information Service (external link)
2 Marsham Street
Tel: 020 7035 4848