Pharmacy Act 2007

18.

Regulation of retail pharmacy businesses.

18.— (1) The Minister may, for the purposes of the health, safety and convenience of the public, make regulations about all or any of the following matters in respect of retail pharmacy businesses:

( a) the manner in which medicinal products are prepared there;

( b) the supervision of those processes there;

( c) the physical characteristics of that part of the premises which is to be provided for the conduct of those processes, including the separation of that part from the rest of the premises;

( d) the facilities to be provided for the conduct of those processes;

( e) the physical characteristics of the part of the premises which is to be used for the storage of medicinal products;

( f) the conditions, (including those relating to temperature, humidity, cleanliness and sanitation) in which medicinal products are prepared, stored, sold, supplied and dispensed there;

( g) the precautions to be taken before medicinal products are sold or supplied there;

( h) the disposal of medicinal products;

( i) the manner in which medicinal products are to be sold or supplied there;

( j) the physical characteristics of that part of the premises which is to be provided for members of the public being sold or supplied with medicinal products or to whom medical prescriptions are being dispensed, and the facilities within that part;

( k) the facilities to be provided and arrangements made there to enable the review, if necessary in private, of the medicinal treatment of a person to whom medicinal products are being or might be sold or supplied and the counselling, if necessary in private, of that person in connection with that treatment;

( l) the keeping of records of and in connection with the sale and supply of medicinal products and the dispensing of medical prescriptions;

( m) the retention, custody, transfer and disposal of those records following the cessation or transfer of the retail pharmacy business;

( n) the use and condition of any apparatus, equipment, utensil or furnishing used for or in connection with the carrying on of the retail pharmacy business;

( o) the safe keeping of medicinal products there.

F12 [ (1A) Regulations made under this section may impose duties on

( a ) a pharmacy owner,

( b ) a pharmacist acting in the capacity specified in section 27( b ), 28( a ) or 29( b ), and who is in personal control of the management and administration of the sale and supply of medicinal products, either where such control is exercised in respect of a single retail pharmacy business or in respect of a number of such businesses, or

( c ) a pharmacist acting in the capacity specified in section 27( c ), 28( b ) or 29( c ), who is in whole-time charge of the carrying on of the retail pharmacy business concerned,

to supervise, in the retail pharmacy business or retail pharmacy businesses in respect of which he or she is the pharmacy owner or such pharmacist, as the case may be, compliance by pharmacists with Chapters 2 and 3 of Part 2 , and Part 3 , of the Health (Pricing and Supply of Medical Goods) Act 2013. ]

(2) In subsection (1), “medicinal product” includes veterinary medicinal products within the meaning of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004.

(3) A person who contravenes a relevant provision shall be guilty of an offence.

(4) In subsection (3), a “relevant provision” is any provision of regulations made under this section designated as such in the regulations.

Annotations:

Amendments:

F12

Inserted (24.06.2013) by Health (Pricing and Supply of Medical Goods) Act 2013 (14/2013), s. 32(b), S.I. No. 202 of 2013.

Editorial Notes:

E37

Power pursuant to subs. (1) exercised (22.02.2016) by Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2016 (S.I. No. 80 of 2016).

E38

Power pursuant to section exercised (29.11.2008 and 1.11.2010) by Regulation of Retail Pharmacy Business Regulations 2008 (S.I. No. 488 of 2008), in effect as per reg. 2.

E39

Regulation of Retail Pharmacy Business Regulations 2008 (S.I. No. 488 of 2008), regs. 5(1)(a), (b), (d) and (f) and 13, in so far as those Regulations relates to veterinary medicinal products, and regs. 4(5), 5(1)(c), 5(3), 6, 8, 11 and 12(1)(b), designated as relevant provisions for purposes of subs. (3) (29.11.2008) by Regulation of Retail Pharmacy Business Regulations 2008 (S.I. No. 488 of 2008), reg. 15, in effect as per reg. 2(1).