9.
Registration number assigned by the Agency
(1) The outer and inner labels of a drug shall show clearly the Agency registration
number (NAFDAC REG. NO.) assigned to it as indicated on the certificate of registration in a
manner prescribed by the Agency.
(2) Where a drug product has tertiary, secondary and primary packaging materials, the
NAFDAC REG. NO. shall be shown on the tertiary and secondary packaging materials.
10.
Identification mark tablets, capsules, etc.
(1) All tablets, capsules, caplets and similar dosage forms shall bear identification marks
traceable to the manufacturer or holder of a certificate of registration of the drug product unless
otherwise exempted by the Agency.
(2) The following classes of drug products are exempt from the requirements in
regulation 10(1):
(a)
drug products intended for use in a clinical trial investigation or bioequivalence
studies;
(b)
radiopharmaceutical drug products;
(c)
drug products with product size, shape, physical characteristics which make
imprinting technologically infeasible or impossible; and
(d)
drugs administered solely in controlled healthcare settings.
(3) Exemptions request shall be made in writing to the Agency giving reasons why a
waiver is justified.
11.
Dispensing measure
All packages for oral paediatric liquid drug or drug products shall have included in them
an appropriate measuring device graduated in 0.5ml to 10ml as applicable.
12.
Package insert
All prescription only drugs shall be accompanied by a package insert with relevant
information as required in these Regulations and any other information as may be required by the
Agency.
13.
Exemptions, etc
(a)
Drugs in 5 cm container.
Notwithstanding the provisions of these Regulations a drug packed in a container
that is 5 cm (or equivalents) or less shall indicate the following:3