Regulation 1 Citation, commencement and interpretation

These Regulations may be cited as the Medicines (Child Safety) Regulations 2003 and shall come into force on 1st October 2003.

In these Regulations—

• “European Economic Area” means the European Economic Area created by the Agreement on the European Economic Area signed at Oporto on 2nd May 1992, as adjusted by the Protocol signed at Brussels on 17th March 1993;

• “first level nurse” means a person registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register;

• “nurse prescriber” means a person—

  1. (a)

     who is a first level nurse, and

  2. (b)

     against whose name is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances.

• “placed on the market” has the same meaning as in regulation 3 of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994^f1;

• “professional register” means the register maintained by the Nursing and Midwifery Council^f2 pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001^f3;

• “relevant medicinal products” means medicinal products for human use consisting of or containing aspirin, paracetamol or more than 24mg of elemental iron which are in the form of tablets, capsules, pills, lozenges, pastilles, suppositories or oral liquids, except for—

  1. (a)

     effervescent tablets containing not more than 25 per cent of aspirin or paracetamol by weight;

  2. (b)

     medicinal products in sachets or other sealed containers which hold only one unit dose;

  3. (c)

     medicinal products which are not intended for—

     1. (i)

        retail sale (including sale by a retail pharmacy business), or

     2. (ii)

        supply (including supply in pursuance of a prescription) in circumstances corresponding to retail sale;

  4. (d)

     medicinal products which are for exportation only;

• “relevant register” means—

  1. (a)

     in relation to a first level nurse, the professional register, and

  2. (b)

     in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954^f4 or the register maintained in pursuance of articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976^f5;

• “supplementary prescriber” means—

  1. (a)

     a first level nurse, or

  2. (b)

     a pharmacist,

• against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber;

• “United Kingdom marketing authorization” has the meaning given in regulation 1(2) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994^f6.