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The Human Medicines Regulations 2012

Status:

This is the original version (as it was originally made).

Regulations 3(13) and 4(5)

SCHEDULE 26Packaging requirements: special provisions

This schedule has no associated Explanatory Memorandum

PART 1Supply by doctors, dentists, nurses and midwives

1.  Where the product is to be administered to a particular individual, the name of that individual.

2.  The name and address of the person who sells or supplies the product.

3.  The date on which the product is sold or supplied.

4.  Such of the following particulars as the person under whose responsibility the product is sold or supplied considers appropriate—

(a)the name of the product or its common name;

(b)directions for use of the product; and

(c)precautions relating to the use of the product.

PART 2Pharmacy exceptions

5.  Where the product is to be administered to a particular individual, the name of that individual.

6.  The name and address of the person who sells or supplies the product.

7.  The date on which the product is sold or supplied.

8.  Where the product is prescribed by an appropriate practitioner, such of the following particulars as the appropriate practitioner who prescribed the product may specify, unless paragraph 9 applies —

(a)the name of the product or its common name;

(b)directions for use of the product; and

(c)precautions relating to the use of the product.

9.  This paragraph applies if a pharmacist, in the exercise of professional skill and judgement, is of the opinion that the inclusion of one or more of the particulars specified in paragraph 8 by the appropriate practitioner who prescribed the product is inappropriate.

10.  Where paragraph 9 applies, the pharmacist may include such particulars, of the same kind as those mentioned in paragraph 8, as the pharmacist thinks appropriate.

11.  Where the product is not prescribed by an appropriate practitioner, directions for use of the product, but these may be omitted in circumstances where section 10(3) of the Medicines Act 1968 applies.

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