Export Certification (human medicines)
Export Certificates can be issued for human medicines and for Irish manufacturers of these. They can include:
- batch certificates
- certificates of free sale for medicines
- certificates of manufacture and free sale
- certificates of pharmaceutical product
- certification of company documents;
- certified copies of manufacturing authorisations
- GMP certificates for both finished products and active substance
- statements of licensing status of pharmaceutical product
In general, these documents are only issued to the marketing authorisation holders or authorised manufacturers of medicines or active substances.
Where the applicant is not the holder of the marketing 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. You can find further information on the types of certificates approved by the WHO in their Guidelines on the implementation of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce document.
What are export certificates used for?
They are typically used to support the registration or renewal of a product authorisation in a 3rd county (outside the EU). They might also be used to accompany a batch of a product if it is a requirement of a Competent Authority in a third country.
What is on a certificate?
The following are product specific certificates, which show the details as approved in the Irish marketing authorisation.
- A Certificate of a Pharmaceutical Product (CPP),
- A Certificate of Free Sale (CFS),
- A Statement of Licensing Status of a Product.
A price certificate shows the cost price for the Irish market.
Other certificates relate to Irish manufacturing sites. For example:
- The CPP can be issued for a product without a Marketing Authorisation but where the dosage form is manufactured in Ireland
- Where the HPRA issues a Good Manufacturing Practice (GMP) certificate for an Irish manufacturer certified copies can be issued.
What do I need to apply?
The application forms and guidance are as follows:
- Application for an export certificate
- Certificate of a pharmaceutical product (English)
- Certificate of free sale (medicinal products)
- Statement of Licensing Status of Pharmaceutical Product
- Certificate of Pharmaceutical Product Explanatory Notes in English
The fee per application is set out in our Guide. For human medicinal products this is Fee Code 351 for standard service. For veterinary medicinal products this is Fee Code 691.
Applications which do not include all the required documentation cannot be validated and will be returned to the applicant.
As per the above guidance, all applications need:
- Completed and signed Application for an Export Certificate
- Proof of payment
- Where required, they should also include the completed draft document.
- Where included, attachments such as composition tables or patient information leaflets.
- A declaration stating that the information provided is true and correct.
There is no requirement to submit a Summary of Product Characteristics. If a SmPC is required to be attached to a CPP, simply note this on the draft and we will attach the latest approved version from our records.