Manufacturers:

• Need to obtain a manfacturer's / importer's authorisation (MIA) from the HPRA before they can certify or release any products processed or imported.
• Must comply with Good Manufacturing Practice (GMP) Guidelines and EU and national legislation.
• Must have a valid GMP certificate. This certificate is issued by the HPRA after each GMP inspection if there is a satisfactory level of compliance.

The HPRA inspects manufacturers to verify compliance with GMP and relevant legislation, as part of the authorisation process and routinely thereafter using risk based criteria.

An authorised manufacturer must apply for HPRA approval for specified changes to its activities prior to certification or release of products concerned. An MIA variation application describing the change should be submitted with supporting documentation.

Contract laboratories that test medicines for veterinary use are required to hold MIA under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).

Contract laboratories that test medicines for human use do not require an MIA if they are included on the contract provider's MIA as a contract laboratory. They will be included in the HPRA's GMP inspection programme and will receive a GMP certificate if they are compliant.

Contract laboratories that perform the following tests may be included on MIAs:

• In-process or finished product testing which are described in a Marketing Authorisation,
• Identity testing of micro-organisms associated with the manufacture of sterile medicinal products, and
• Identity testing of starting materials.

The Control of Manufacture Regulations provides an exemption for the extemporaneous preparation or manufacture of medicines. This exemption applies to processes where a registered pharmacist or dentist uses traditional compounding techniques to produce a medicine to meet the special needs of a patient, or group of patients, when no suitable authorised medicinal product is available.

Article 61(5) of the Clinical Trial Regulation (CTR) (EU Regulation 536/2014) provides an exemption from the requirement to hold a MIA for certain processes, where they are carried out in a hospital, health centre or a clinic participating in the clinical trial. These are:

• Re-labelling or re-packaging of the investigational medicinal product (IMP),
• Preparation of radiopharmaceuticals used as diagnostic IMPs,and
• Preparation of an IMP in accordance with a doctor's prescription or in accordance with a pharmacopoeial monograph.

Wholesalers who hold a Wholesale Distributor's Authorisation (WDA) are permitted to import exempt medicinal products for supply to Irish patients under their WDA.