The Human Medicines Regulations 2012

PART 1 Particulars to be included in a patient group direction

1.  The period during which the direction is to have effect.

2.  The description or class of medicinal product to which the direction relates.

3.  The clinical situations which medicinal products of that description or class may be used to treat or manage in any form.

4.  Whether there are any restrictions on the quantity of medicinal product that may be sold or supplied on any one occasion and, if so, what restrictions.

5.  The clinical criteria under which a person is to be eligible for treatment.

6.  Whether any class of person is excluded from treatment under the direction and, if so, what class of person.

7.  Whether there are circumstances in which further advice should be sought from a doctor or dentist and, if so, what circumstances.

8.  The pharmaceutical form or forms in which medicinal products of that description or class are to be administered.

9.  The strength, or maximum strength, at which medicinal products of that description or class are to be administered.

10.  The applicable dosage or maximum dosage.

11.  The route of administration.

12.  The frequency of administration.

13.  Any minimum or maximum period of administration applicable to medicinal products of that description or class.

14.  Whether there are any relevant warnings to note and, if so, what warnings.

15.  Whether there is any follow up action to be taken in any circumstances and, if so, what action and in what circumstances.

16.  Arrangements for referral for medical advice.

17.  Details of the records to be kept of the supply, or the administration, of products under the direction.