The Human Medicines Regulations 2012

Exceptions to regulation 249

250.—(1) This regulation makes provision for exceptions to regulation 249.

(2) A person may sell by way of wholesale dealing a pharmacy medicine which is for the purpose of being administered to human beings in the course of a business to any person carrying on such a business.

(3) A person may sell by way of wholesale dealing a pharmacy medicine to which a general sale exemption applies to any person who by virtue of that exemption may sell the pharmacy medicine by retail, or supply it in circumstances corresponding to retail sale, otherwise than by or under the supervision of a pharmacist.

(4) In paragraph (3) “general sale exemption” means an exemption from regulation 220 conferred by a provision of Chapter 3.

(5) A person may sell by way of wholesale dealing to a person specified in column 1 of Parts 1 to 3 of Schedule 17 a prescription only medicine specified in relation to that person in column 2 of Parts 1 to 3 of that Schedule.

(6) A person may sell by way of wholesale dealing to a registered optometrist a product that is a prescription only medicine by reason only that it contains one or more of the following substances—

(a) amethocaine hydrochloride;

(b) lidocaine hydrochloride;

(c) oxybuprocaine hydrochloride; or

(d) proxymetacaine hydrochloride.

(7) A person may sell by way of wholesale dealing to an additional supply optometrist a product that is a prescription only medicine by reason only that it contains thymoxamine hydrochloride.

(8) A person may sell by way of wholesale dealing to a registered dispensing optician a prescription only medicine that—

(a) is required for use by a registered optometrist or doctor attending the optician’s practice; and

(b) contains one or more of the following substances—

(i) amethocaine hydrochloride,

(ii) chloramphenicol,

(iii) cyclopentolate hydrochloride,

(iv) fusidic acid,

(v) lidocaine hydrochloride,

(vi) oxybuprocaine hydrochloride,

(vii) proxymetacaine hydrochloride, and

(viii) tropicamide.

(9) A person may sell by way of wholesale dealing to a registered dispensing optician a prescription only medicine that—

(a) is required for use by the optician in the course of a professional practice as a contact lens specialist; and

(b) contains one or more of the following substances—

(i) lidocaine hydrochloride,

(ii) oxybuprocaine hydrochloride, and

(iii) proxymetacaine hydrochloride.

(10) In this regulation—

“additional supply optometrist” means a person who is registered as an optometrist, and against whose name particulars of the additional supply speciality have been entered in the relevant register;

“contact lens specialist” means a person who is a registered dispensing optician and against whose name particulars of the contact lens speciality have been entered in—

(a)

the register of dispensing opticians maintained under section 7(b) of the Opticians Act 1989; or

(b)

the register of visiting dispensing opticians from relevant European States maintained under section 8B(1)(b) of that Act.