Pursuant to section 105 of the Medicines Act 1981, His Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations and bodies appearing to the Minister to be representative of persons likely to be substantially affected by them, and acting on the advice and with the consent of the Executive Council, makes the following regulations.

1 Title

(1) These regulations are the Medicines Amendment Regulations 2000.

(2) In these regulations, the Medicines Regulations 1984¹ are called “the principal regulations”.

2 Commencement

(1) Regulations 3 to 10 and 12 to 14 come into force on the 28th day after the date of the notification of these regulations in the Gazette.

(2) The rest of these regulations come into force on the day after the date of their notification in the Gazette.

3 Labelling of medicines

(1) Regulation 13(1) of the principal regulations is amended by revoking paragraph (d), and substituting the following paragraph:
- “(d) the words ‘Batch Number’ or ‘Lot Number’, or the word ‘Batch’ or ‘Lot’, or the symbol ‘B’ (whether alone or within a circle), followed by the batch number or lot number of the medicine:”.
(2) Subclauses (8)(c) and (9)(c) of regulation 13 of the principal regulations are revoked.

4 Labelling of related products

Regulation 14(1) of the principal regulations is amended by revoking paragraph (e), and substituting the following paragraph:
- “(e) the words ‘Batch Number’ or ‘Lot Number’, or the word ‘Batch’ or ‘Lot’, or the symbol ‘B’ (whether alone or within a circle), followed by the batch number or lot number of the related product:”.

5 Principal display panel

Regulation 15 of the principal regulations is amended by revoking subclause (2), and substituting the following subclause:
- “(2) The principal display panel of the label of a related product must contain the matters required by paragraphs (a) to (c) of regulation 14(1).”

6 Exemptions from regulations 13 and 14

Regulation 16(1) of the principal regulations is amended by revoking paragraph (a), and substituting the following paragraphs:
- “(aa) a medicine or related product, in primary containers that are not intended for separate sale and are packed in a sealed unit that—
  
  “(i) is formed from sheet material; and
  
  “(ii) does not exceed 35 mm in its greatest dimension; and
  
  “(iii) is within a larger container that complies with regulation 13 or regulation 14 (as the case requires); or
- “(ab) a medicine or related product, in primary containers that are not intended for separate sale and are packed in a strip of sealed units that—
  
  “(i) is formed from sheet material; and
  
  “(ii) bears the manufacturer's batch number; and
  
  “(iii) is within a larger container that complies with regulation 13 or regulation 14 (as the case requires); or
- “(ac) a sterile medicine, in a primary container that—
  
  “(i) is not intended for separate sale; and
  
  “(ii) is too small to be labelled in compliance with regulation 13 or regulation 14; and
  
  “(iii) is within a larger container that complies with regulation 13 or regulation 14 (as the case requires); or”.

7 Form and manner of labelling

(1) Regulation 17(1)(a) of the principal regulations is amended by omitting the words “uniform colour contrasting strongly with a uniform”, and substituting the words “a colour or colours contrasting strongly with the statement's”.

(2) Regulation 17(1)(g) of the principal regulations is revoked.

8 Size of letters

(1) Regulation 18 of the principal regulations is amended by revoking subclause (1), and substituting the following subclause:
- “(1) A minimum size of lettering used on labels that is prescribed by these regulations refers to the height of capital letters, or lower case letters with an ascender or descender, in the typeface used.”
(2) Subclauses (2) to (4) and (7) of regulation 18 of the principal regulations are revoked.

9 Consumer information panel

Paragraphs (a) and (b) of regulation 20(1) of the principal regulations are revoked.

10 Prescriptions not required in certain cases

(1) Regulation 44 of the principal regulations is amended by omitting the words “Nothing in this Part of these regulations shall apply to the sale or dispensing of a prescription medicine if the medicine”, and substituting the words “A prescription medicine may be sold or dispensed otherwise than under a prescription given by a practitioner, registered midwife, veterinarian, or designated prescriber if it”.
(2) Regulation 44 of the principal regulations is amended by revoking paragraph (i), and substituting the following paragraphs:
- “(i) the master of a New Zealand ship within the meaning of the Maritime Transport Act 1994,—
  
  “(i) if the medicine is prescribed by rules under section 36(1)(e) of that Act; or
  
  “(ii) at a time before the commencement of the first rules made under section 36(1)(e) of that Act, if the medicine is authorised or required by scales issued under section 138 or section 239 of the Shipping and Seamen Act 1952; or
  
  “(ia) the master of a foreign ship within the meaning of the Maritime Transport Act 1994, if the law of the State whose flag the ship is entitled to fly requires the master to carry the medicine; or”.

11 New Part 7A inserted

The principal regulations are amended by inserting, after Part 7, the following Part:
“Part 7A
“Export of prescription medicines

“44C No export of prescription medicines for retail sale without New Zealand prescription

“(1) No person may export a prescription medicine in the course or for the purpose of retail sale, otherwise than under a prescription given by a practitioner, a registered midwife, or a designated prescriber.

“(2) The meaning of retail sale in subclause (1) must be determined by reference to section 5(2) of the Act.

“(3) Subclause (1) is intended to limit the sale and supply of prescription medicines pursuant to section 33(b) of the Act.”

12 New regulations 54A and 55 substituted

The principal regulations are amended by revoking regulation 55, and substituting the following regulations:
“54A Sale of Medicines Registers

“(1) This regulation applies to the sale of a medicine if it is—

“(a) a restricted medicine sold by retail otherwise than under a prescription; or

“(b) a prescription medicine, restricted medicine, or pharmacy-only medicine, sold by wholesale.

“(2) A person who makes sales to which subclause (1) applies must—

“(a) maintain a Sale of Medicines Register for recording and keeping the information stated in subclause (4); and

“(b) ensure that the information kept in it is arranged in such a way that the information about each particular sale can be conveniently inspected, or retrieved and inspected.

“(3) The register must be in 1 or more of the following forms:

“(a) a system for recording and keeping the information electronically:

“(b) a book for recording and keeping the information in writing:

“(c) some other system for recording and keeping the information, approved by the Director-General (either generally or in any particular case) for the purposes of this regulation.

“(4) The information to be recorded and kept in relation to each sale is—

“(a) the date of the sale:

“(b) the buyer's name:

“(c) the address of the buyer's place of business or residence:

“(d) the name of the medicine sold:

“(e) the quantity of the medicine sold:

“(f) the name of the person making the sale.
“55 Records of sales by retail or wholesale

“(1) Before giving to the buyer a medicine to whose sale regulation 54A(1) applies, the person making the sale must record in the Sale of Medicines Register maintained under regulation 54A(2) the information stated in regulation 54A(4).

“(2) It is not necessary to comply with subclause (1) in relation to a sale by wholesale if the information stated in regulation 54A(4) can be discovered from the seller's books and records.”

13 New regulation 58 substituted

The principal regulations are amended by revoking regulation 58, and substituting the following regulation:
“58 Records to be kept

“(1) The person responsible for a record to which this Part applies must keep it for at least 3 years after it was made (or, if it is kept together with other records, for at least 3 years after the most recent of them was made).

“(2) The person must keep the record—

“(a) in a secure place at his or her place of business; or

“(b) in some other place authorised by the licensing authority.”

14 New Schedule 1 substituted

[Revoked]

Regulation 14 was revoked, as from 30 June 2002, by regulation 3(2)(a) Medicines Amendment Regulations 2002 (SR 2002/134).

r 14(1)

[Revoked]

The Schedule was revoked, as from 30 June 2002, by regulation 3(2)(a) Medicines Amendment Regulations 2002 (SR 2002/134).

Marie Shroff,

Clerk of the Executive Council.

Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations amend the Medicines Regulations 1984 (the principal regulations).

Regulation 11 (which relates to the export of prescription medicines for retail sale) comes into force on the day after the notification of the regulations in the Gazette, and the other substantive provisions of the regulations come into force 27 days later.

Regulations 3 to 9 make technical amendments to provisions of the principal regulations relating to the labelling of medicines and related products.

Regulation 10 updates regulation 44 of the principal regulations (which relates to the provision of medicines to the masters of ships without a prescription) to take account of the enactment of the Maritime Transport Act 1994.

Regulation 11 inserts into the principal regulations a new Part 7A, which prohibits the export of prescription medicines for retail sale without a New Zealand prescription.

Regulations 12 and 13 update provisions relating to Sale of Medicines Registers (in which pharmacists and wholesalers are required to record details of some sales) so that modern technology may be used to record and keep the details.

Regulation 14 replaces Schedule 1 of the principal regulations with an updated schedule that takes account of the various additions and other changes that have been made to it by notices in the Gazette since it was last replaced on 16 July 1999.

Issued under the authority of the Acts and Regulations Publication Act 1989.

Date of notification in Gazette: 2 November 2000.

1 SR 1984/143

Medicines Amendment Regulations 2000