Citation, commencement and interpretation

1. —(1) This Order may be cited as the Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2006 and shall come into force on 17th November 2006.

(2) In this Order—

“the POM Order” means the Prescription Only Medicines (Human Use) Order 1997( 4 ); and

“the Pharmacy and General Sale Order” means the Medicines (Pharmacy and General Sale—Exemption) Order 1980( 5 ).

Amendment of article 1 of the POM Order

2. In article 1 of the POM Order (citation, commencement and interpretation), in paragraph (2)—

(a) after the definition of “inhaler”, insert the following definition—

“ “IRME practitioner” means, in relation to a medical exposure, a practitioner for the purposes of the Ionising Radiation (Medical Exposure) Regulations 2000 ( 6 ) ; ” ;

(b) after the definition of “maximum strength”, insert the following definition—

“ “medical exposure” has the same meaning as in the Ionising Radiation (Medical Exposure) Regulations 2000; ” ;

(c) in the definition of “medicinal product”, omit the words from “, but does not include” to the end;

(d) for the definition of “operator”, substitute the following definition—

“ “operator”—

(e) after the definition of “prolonged release”, insert the following definition—

“ “radioactive medicinal product” means a medicinal product which is, which contains or which generates a radioactive substance and which is, contains or generates that substance in order, when administered, to utilize the radiation emitted therefrom; ” .

Insertion of article 7B of the POM Order

3. After article 7A of the POM Order insert the following article—

“ Exemption for administration by operators

7B. —(1) The restriction imposed by section 58(2)(b) (restriction on administration) shall not apply to—

(a) a radioactive medicinal product, administration of which results in a medical exposure; or

(b) any other prescription only medicine if it is being administered in connection with a medical exposure,

where the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to in paragraph (1) are that—

(a) the radioactive medicinal product or other prescription only medicine is administered by an operator acting in accordance with the procedures and protocols referred to in regulation 4(1) and (2) of the Ionising Radiation (Medical Exposure) Regulations 2000 which apply to the exposure referred to in paragraph (1);

(b) that medical exposure has been authorised by an IRME practitioner or, where it is not practicable for an IRME practitioner to authorise the exposure, by an operator acting in accordance with written guidelines issued by an IRME practitioner;

(c) the IRME practitioner is the holder of a certificate granted pursuant to the Medicines (Administration of Radioactive Substances) Regulations 1978 ( 7 ) ;

(d) the radioactive medicinal product or other prescription only medicine is not a controlled drug; and

(e) in the case of a prescription only medicine which is not a radioactive medicinal product, it is specified in the protocols referred to in sub-paragraph (a). ”

Amendment of Schedule 5 to the POM Order

4. —(1) Schedule 5 to the POM Order (exemption for certain persons from section 58(2) of the Act) is amended as follows.

(2) In Part I (exemption from restrictions on sale or supply)—

(a) in column 1 (persons exempted), for paragraph 10 substitute the following paragraph—

“ 10. Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2. ” ; and

(b) in column 2 (prescription only medicines to which the exemption applies), in paragraph 10—

(i) in sub-paragraph (c), after “volume;” omit “and”,

(ii) in sub-paragraph (d), for “in weight.” substitute “in weight; and”, and

(iii) at the end, add—

“ (e) Amoxicillin;

(f) Erythromycin;

(g) Flucoxacillin;

(h) Tioconazole 28%; and

(i) Silver Sulfadiazine. ”

(3) In Part II (exemptions from the restriction on supply), after paragraph 7 insert—

(4) In Part III (exemptions from restriction on administration)—

(a) in column 1 (persons exempted), for paragraph 1 substitute the following paragraph—

“ 1. Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2. ” ; and

(b) in column 2 (prescription only medicines to which the exemption applies), in paragraph 1, insert at the appropriate place in the alphabetical order of entries as they appear in that paragraph—

“ Adrenaline

Levobupivacaine hydrochloride

Methylprednisolone

Ropivacaine hydrochloride ” .

Amendment of Schedule 1 to the Pharmacy and General Sale Order

5. —(1) Schedule 1 to the Pharmacy and General Sale Order (exemptions for certain persons from sections 52 and 53) is amended as follows.

(2) In Part I—

(a) in column 1 (persons exempted)—

(i) in paragraph 1, for “State registered” substitute “Registered”, and

(ii) for paragraph 1A substitute the following paragraph—

“ 1A. Registered chiropodists against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2. ” ; and

(b) in column 2 (medicinal products to which the exemption applies)—

(i) in paragraph 1, in sub-paragraph (c)—

(aa) after “Glutaraldehyde” insert “1.0 per cent Griseofulvin”, and

(bb) after “acid” insert “1.0 per cent Terbinafine”, and

(ii) in paragraph 1A(a)—

(aa) after “volume;” omit “and”, and

(bb) after “1 per cent by weight in weight;” insert—

“ (v) Amoxicillin;

(vi) Erythromycin;

(vii) Flucoxacillin;

(viii) Tioconazole 28%; and

(ix) Silver Sulfadiazine; ” .

(3) In Part II, after paragraph 14 insert—