Active substance registration for veterinary medicines

Importers, manufacturers and distributors of active substances established in Ireland are required to register their activity with the HPRA. The registration form should be submitted at least 60 days before the start of operations. An annual update confirming the registration details are correct is required.

Information on any changes that have occurred that may impact the quality and safety of the active substances that are manufactured, imported or distributed needs to be notified to the HPRA immediately.

Manufacturers of medicines who hold a manufacturer's / importer's authorisation (MIA) should register activities related to active substance manufacture, importation or distribution.

How to apply for registration

Before applying for an active substance registration it is necessary to register with the European Medicines Agency Organisation Management System (OMS).

To apply for active substance registration (ASR), you must complete an Application for Registration of Manufacturer, Importer or Distributor of Active Substances.

You can find information on how to fill in the application form in Appendix I of our Guide to Registration Requirements for Active Substances Manufacturers Importers and Distributors in Ireland. Appendix II of the Guide provides worked examples to demonstrate a completed form.

There is a fee in relation to the activities being registered. Please refer to our published guidance for further details.

How We Regulate Manufacturers, Importers and Distributors of Active Substances

• Manufacturers, importers and distributors based in Ireland must register their details with the HPRA before they can release any active substances.
• Manufacturers and importers must comply with Good Manufacturing Practice (GMP) Guidelines for active substances as well as EU and national legislation.
• Distributors must comply with Good Distribution Practice (GDP) Guidelines for active substances as well as EU and national legislation.
• The HPRA inspects manufacturers, importers and distributors to verify compliance with GMP and GDP as part of the registration process and then routinely.

Importing Active Substances into the EU

All active substances that are manufactured outside the EU and are imported for the manufacture of medicines have to be accompanied by a written confirmation from the regulatory authority of the exporting country. These statements are issued per manufacturing site and per active substance and are part of the EU system to ensure that standards of good manufacturing practice (GMP) are equivalent to those in force in the EU. Exporting countries with an 'equivalent' regulatory framework do not need to issue written confirmations. The European Commission maintains a webpage detailing the status of the equivalent countries.

Applications to withdraw an active substance registration

The withdrawal of an active substance registration may be initiated:

• At the request of the registration holder.
• If the HPRA's Compliance department receives information concerning other business-related situations which might necessitate the withdrawal of a registration. For example, information that a company is going into liquidation.

When can I apply to withdraw my registration?

You can apply to withdraw a registration when the company has stopped trading under the General Conditions of the authorisation.

Reasons for withdrawal can be:

• Commercial,
• Quality, including GMP issues,
• Safety issues,
• Efficacy issues,
• Other.

How do I apply to withdraw my Authorisation?

You must complete the Application to withdraw an authorisation licence approval or registration form.

You must make sure the application form is:

• Completed in full.
• Bears the signature of the applicant. Where the application is on behalf of a limited company, the declaration must be signed by a director or the secretary and, in the case of a partnership, by a partner.
• Submitted to the return details provided on the form.