Export certification
Introduction of electronic signatures for export certificates
The HPRA have introduced the option of requesting an electronic version of the Certificate of Pharmaceutical Product and Free Sale Certificate with a digital signature to those applicants who may prefer to receive certificates in this format. The option to request printed versions of documents with a wet signature will remain in place and this initiative will apply to both medicinal products and cosmetics.
The application process will remain the same but it should be noted on the updated application form that you wish to receive an electronic version of the certificate and any attachments that may be requested. Any SPC requested will be the latest version downloaded from the HPRA website, we do not accept an SPC submitted by the applicant, simply note the requirement on the CPP draft.
The certificate will be emailed back to the applicant’s email address.
This service is now live.
For queries relating to this initiative please email exportcerts@hpra.ie.
What is the export certificates section responsible for?
The export certificates section is responsible for issuing export certificates for human or veterinary medicinal products and for Irish manufacturers of these. The documents issued are:
- batch certificates
- certificates of free sale for medicinal products
- 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 API
- statements of licensing status of pharmaceutical product
In general, these documents are only issued to the marketing authorisation holders or authorised manufacturers. 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. Further information on the types of certificates approved by the WHO is available at the following link:
Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce.
What are the certificates used for
These certificates are typically used to register or renew a product authorisation in a 3rd county (outside the EU). They might also be typically used to accompany a batch of that product as required by a foreign competent authority. The Certificate of a Pharmaceutical Product (CPP)/ Certificate of Free Sale(CFS)/ Statement of Licensing Status of a Product are all product specific certificates, used to show the details as approved in the Irish marketing authorisation. A Price Certificate shows the cost price for the Irish market.
The CPP can also be issued for a product without a Marketing Authorisation but where the dosage form is manufactured in Ireland, once the application is accompanied by a signed company declaration to state that the details are true. Please check the Useful Links section below for a draft of certificates for whichever best suits your requirements.
Where a company has been inspected and found to be GMP compliant by the HPRA, certified copies of a company’s GMP certificate can be issued.
A CPP is the most typically issued document that is provided, guidance in completing the form accurately under each section has been provided in the draft CPP in English on our website. All certificates are issued as per their standard formats. The only document to which additional information may be attached (package leaflet, labels, composition page) is the CPP. When applying, all additional attachments must be accompanied by a declaration letter stating that the information in them is true and correct.
What is required to make an application
All applications received should include:
- 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
- Must be accompanied by a letter stating that the information in them is true and correct
- There is no requirement to submit a Summary of Product Characteristics, if one 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.
The fee per application is set out in the Guide to Fees, 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 of the required documentation cannot be validated, and will be returned to the applicant.
Useful links
Application form for Export Certificates
Certificate of Pharmaceutical Product (English) (French) (Spanish)
Certificate of free sale
Statement of Licensing Status of Pharmaceutical Product
Certificate of a Pharmaceutical Product Explanatory Notes in English