Amendment of the Medicines (Pharmacy and General Sale—Exemption) Order 19802

The Medicines (Pharmacy and General Sale—Exemption) Order 19803 shall be amended as follows–

a

in article 1(2)(a), the following definition is inserted after the definition of “prescription only medicine”–

  • “registered homoeopathic medicinal product for human use” means a homoeopathic medicinal product in respect of which a certificate of registration granted pursuant to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 19944 is in force,

b

in article 2, paragraphs (3) and (4) are revoked,

c

after article 6, the following article is inserted–

Exemption for certain registered homoeopathic medicinal products for human use

6A

1

The restrictions imposed by sections 52 and 53 shall not apply to the sale or supply, offer or exposure for sale or supply of a registered homoeopathic medicinal product for human use other than an excluded product if and so long as the person selling or supplying the registered homoeopathic medicinal product for human use has been requested by or on behalf of a particular person and in that person’s presence to use his own judgment as to the treatment required.

2

The restrictions imposed by section 52 shall not apply to the sale or supply, offer or exposure for sale or supply of a registered homoeopathic medicinal product for human use other than an excluded product if and so long as the conditions specified in section 53 are fulfilled.

3

For the purposes of paragraphs (1) and (2) above a product is an excluded product if it is–

a

a prescription only medicine,

b

a controlled drug, or

c

in a class specified in Schedule 3 to the Medicines (General Sale List) Order 19845.

d

in Part I of Schedule 1, in paragraph 11–

i

in the entry in column 1, there are inserted, after the words “holders of marketing authorizations within the meaning of the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994”, the words “, holders of certificates of registration granted pursuant to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994”, and

ii

in the entry in column 2, the word “or” is deleted and there are inserted, after the words “marketing authorizations”, the words “or certificates of registration”.