Wholesale Licensing

Manufacture Authorisation

The regulations on the manufacture of medicinal products are based on EU Directives.  The competent authority is the Health Products Regulatory Authority.

A manufacturer’s authorisation allows the manufacture of medicinal products for supply in the European Economic Area (EU plus EFTA countries) or for export outside the EEA.  The manufacture of ingredients per se may not require a licence but is required to ensure that they comply with the guidelines on manufacturing.

The legislation sets out the due process and procedures relating to the application for a licence.

Exceptions

There are a number of exemptions from the requirement for a manufacturer’s authorisation.

• the manufacture of a product in reply to a bona fide unsolicited offer to procure a special need carried out in a pharmacy under the supervision of a pharmacist in accordance with specifications of a registered dentist or doctor for use by individual patients under his or her responsibility or
• to maintain a stock of medicinal products for dispensing exclusively to meet the orders of such doctors or dentists in accordance with prescriptions of a pharmacopoeia for supply to patients attending the pharmacy.
• supply as above under the personal supervision of a doctor or dentist for use by his individual patients under his direct personal responsibility, provided the product is not advertised and no other suitable authorised product is available.
• preparation comprising of changes in packaging or presentation of medicinal products in the pharmacy under the supervision of a pharmacist or a doctor for patients under his care;
• non-industrial produced herbal medicinal products supplied without recommendation for use in a trade name; process of drawing, crushing or commuting herbal plants is not considered to be industrial. In the case of homeopathic medicines, which are not industrially produced and which are supplied without any written recommendation for use without a trade name, the process of dilution or succession or potentisation for homeopathic stocks for individual patients are not industrial. The e process of drawing, crushing and commuting herbal plants is not industrial;
• preparation of radiopharmaceutical products at the time when it is due to be administered by or under the supervision of a person administering it in accordance with the manufacturer’s instructions from an authorised kit generator or precursor in an establishment licensed by the Radiological Protection Institute of Ireland to use such products.

Manufacturing Requirements

All manufacturing must take place in accordance with good manufacturing practices as set out in EU Directives.  General requirements apply to all holders, including

• provision and maintenance of staff, facilities, premises necessary for manufacturing.
• manufacturing, in accordance with the requisite standards of quality, strength and purity.
• keeping batch records and samples for every product for a minimum of five years.
• having systems for recording and investigating complaints.
• having records to facilitate recalls.
• supplying only to authorised wholesalers or other persons entitled to supply the product.
• providing information to the regulator and allowing it to inspect, take samples; complying with the specific directions in relation to wholesale supply.

There are provisions for the variation, revocation and suspension of authorisation.  Due process applies.

Ongoing Obligations

A manufacturing license requires that there be at least one qualified person with qualifications and experience.  They must have studied at least one of the disciplines of pharmacy medicine, veterinary medicine, chemistry, pharmaceutical chemistry, technology or biology and have covered certain basic topics.   They must have two years’ experience in pharmaceutical manufacturing operations.

In most cases, the person concerned has certain duties and obligations. The qualified person must certify in a register that every batch has been manufactured in accordance with the relevant regulations, authorisation and other requirements.  He must certify products imported from outside the EEA have been manufactured in accordance with good manufacturing practices and subjected to appropriate tests and analysis.

Certain Imports

A product that is otherwise unauthorised, which is sold or supplied in response to a bona fide unsolicited offer, by a dentist or doctor for use by individual patients in order to fulfil special needs of those patients is an exempt medicinal product.  A manufacturer’s authorisation is required to import such products.  They must only be imported in accordance with conditions.

Records must be kept by the importer in respect of each exempt medicinal product including

• names,
• nature of manufacture,
• list of ingredients,
• quantity imported,
• batch number,
• names and addresses of the manufacturer.

Details of each sale and supply must be recorded, including batch numbers and particulars of suspected adverse reactions and defects.

There are limitations on advertisements in relation to imported products by the importers.  The regulator must be notified of importation of products are generally done electronically.  The medicines regulator may direct cessation of importation or supply.

Wholesalers Authorisations

Wholesalers of medicinal products must hold a wholesaler’s license authorization. A sale by wholesale is a sale in the course of a business or for the administration of patients in the course of professional practice.

Broadly similar provisions apply to a wholesaler.  An application for authorisation is similar to that for a manufacturer’s authorisation. There are obligations in relation to product type, operational matters, and premises in which medicines are stored and distributed. Requirements in relation to records, product recall, batch number, stock control etc., are applicable.

The wholesaler’s authorisation is for particular types of medicinal product wholesaling operations and premises in which they may be undertaken. There are exemptions from wholesaler authorisation requirements in the case of

• supply of products in clinical trials,
• sale under the personal supervision of a pharmacist to a doctor, dentist, optician, veterinary surgeon, certain other health professionals, etc.
• sale of a medicinal product by a person who has manufactured or imported it from a third country in accordance with the manufacturer’s authorisation.
• sale under the personal supervision of a pharmacist to a person lawfully entitled to obtain the same for administration to patients in the course of business at a hospital.

Ongoing Wholesale Obligations

Wholesalers must comply with the good distribution practice, in accordance with EU published guidelines.  This involves quality assurance in respect of transport, handling, storage and traceability.  It requires the requisite premises, personnel, plant, equipment, processes, record-keeping, etc.

The wholesaler must appoint a responsible person, with the requisite knowledge and experience to the satisfaction of the regulator.  That person must ensure compliance with all legislation requirements and licensing provisions.  The IMP may suspend the approval of the person concerned.

A wholesaler must obtain supplies from authorised manufacturers or other authorised wholesalers within the EEA.  It may only sell products covered by the terms of the authorisation/licensing.

Administration & Enforcement

The regulator may appoint officers to inspect and obtain information in accordance with general regulatory powers in order to ensure ongoing compliance with the requirements.

Records must be kept of all products supplied and dispatched, including dates, details of consignee, supplier, etc.  They must be maintained for five years. They must be capable of identifying products in batches that may not conform with requirements.

Dispatch notes must be kept and retained in respect of supplies and sales. The requirements also apply to importers of parallel importers from other EU States.

There are procedural provisions in respect of the grant, revocation, suspension and variation of the terms of a wholesaler’s authorisation.   Wholesalers may be authorised to import from other EU States for distribution under the terms of their authorisation.  Broadly, similar obligations apply as apply generally.