Exemptions from Medicines Act restrictions

POMs are subject to the additional requirement that they are sold or supplied in accordance with an appropriate practitioner's prescription. The law also restricts the administration of parenteral medicines which, if not self-administered, must be administered by a doctor or, in certain circumstances an independent nurse prescriber or a supplementary prescriber. Parenteral medicines can also be administered by anyone acting in accordance with the patient-specific directions of a doctor or, again in certain circumstances, an independent nurse prescriber or a supplementary prescriber.

Exemptions: How they differ from prescribing and use of Patient Group Directions (PGDs)
There are a range of exemptions from these restrictions which allow certain groups of health professional to sell, supply and administer particular medicines direct to patients. The exemptions are distinct from prescribing which requires the involvement of a pharmacist in the sale or supply of the medicine. They also differ from the arrangements for Patient Group Directions (PGDs) as the latter must comply with specific legal criteria, be signed by a doctor or dentist and a pharmacist and authorised by an appropriate body.

Mechanism for creating new exemptions
The MHRA would consider adding further exemptions to allow additional groups of health professional to sell, supply and/or administer medicines where there was a clear case for doing so. In the first instance, we would envisage a formal approach from the relevant representative body, setting out the rationale for any proposed exemption, details of the medicines involved and information relating to arrangements for suitable training in the correct circumstances for safe use and administration of the medicines. As any proposed new exemptions would require an amendment to medicines legislation, there is a statutory requirement for Ministers to consult interested organisations and to take account of any advice from the Commission on Human Medicines.