The Export Certificates section is responsible for issuing Export Certification for human or veterinary medicinal products. The documents issued out are:
- Certificate of Pharmaceutical Product
- Certificate of Free Sale for Medicinal Products
- Price Certificate
- Certified copies of a company’s GMP certificate
- Statement of Licensing Status of Pharmaceutical Product
- Certification of other documents from a company
These documents are only issued to the product authorisation holders or authorised manufacturers. Where the applicant is not the holder of the product authorisation or manufacturing authorisation, a letter of authorisation from the holder must be provided. Where possible, certificate formats, as published by the World Health Organisation, are used.
What are the certificates used for
The Certificate of Pharmaceutical Product/ Certificate of Free Sale/ Price Certificate/ Statement of Licensing Status of a Product are all product specific certificates, used to show the details as approved for the Irish market.
These are only issued for products with a valid Marketing Authorisation, with the except of the CPP which can be issued for products without a Marketing Authorisation, once accompanied by a signed company declaration to state that the details are true. Please check the draft documents for whichever best suits your requirements.
Where a company has been inspected by HPRA, certified copies of a company’s GMP certificate can be issued.
All certificates are issued as per their drafts, the only document to which additional information may be attached (PIL, labels, composition page) is the Certificate of Pharmaceutical Product. All additional attachments must be accompanied by a declaration letter stating that the information on them is true and correct.
What is required to make an application
- All applications received should include:
- Completed Application for an Export Certificate
- Fee application form, with proof of payment
- Where required they should also include the completed draft document
The fee per application is set out in the Guide to Fees, for human medicinal products this is €147 (Fee Code 351) for standard service, €277 (Fee Code 352) for fast-track applications. For veterinary medicinal products this is €141 (Fee Code 691) and €266 (Fee Code 692) for fast-track applications.
Applications which do not include all of the required documentation cannot be validated, and will be returned to the applicant.