Annex 8
to Item 6.1 (j) of the Procedure for
Conducting Expert Evaluation of Materials
Pertinent to Medicinal Products Submitted for
the State Registration (Re-registration) and
for Expert Evaluation of Materials about
Introduction of Changes to Registration
Documents during Validity Period of
Registration Certificate
Package leaflet for prescription only medicinal product or medicinal product, used
in hospitals and summary of product characteristics
1. Package leaflet shall obligatory accompany all prescription only medicinal products if the
information required by Annex 9 of this Procedure is not stated on the outer or immediate
packaging.
2. The package leaflet must be clear, understandable, in Ukrainian or other international
language, as specified by the legislation of Ukraine. This shall not prevent the package leaflet
being printed in several languages, provided that the same information is given in all the
languages used.
3. For some medicinal products the requirement to indicate in package leaflet some data in
Ukrainian or other international language in Ukraine may be canceled provided that medicinal
product is not intended for self-medication.
4. Package leaflet shall be printed in not less than 8 Didot’ type with the distance between lines
not less than 3 mm.
5. Package leaflet and summary of the product characteristics shall contain the following
information:
5.1. Name of medicinal product;
5.2. Qualitative and quantitative composition in terms of the active substances and constituents
of the excipient, knowledge of which is essential for proper administration of the medicinal
product. The usual common name or chemical description shall be used;
But if medicinal product is intended for parenteral administration or local use or for
ophthalmology, all exipients shall be stated.
5.3. Pharmaceutical form;
5.4. Pharmacological properties and, in so far as this information is useful for therapeutic
purposes, pharmacokinetic particulars;
5.5. Clinical particulars:
5.5.1. Therapeutic indications;
5.5.2. Contra-indications;
5.5.3. Adverse reactions (frequency and seriousness);
5.5.4. Special precautions to be taken by persons handling the products and administering them
to patients, together with any precautions to be taken by the patient;
5.5.5. Use during pregnancy and lactation;
5.5.6. Interaction with other medicaments and other forms of interaction;
5.5.7. Posology and method of administration for adults and, where necessary, for children;
5.5.8. Overdose (symptoms, emergency procedures, antidotes);
5.5.9. Special warnings;
5.5.10. Effects on ability to drive and to use machines;
5.6. Pharmaceutical particulars:
5.6.1. Major incompatibilities;
5.6.2. Shelf life, when necessary after reconstitution of the medicinal product or when the
immediate packaging is opened for the first time;
5.7. Special precautions for storage;
5.8. Nature and contents of the immediate packaging;
5.9. Special precautions for disposal of unused medicinal products or waste materials derived
from such medicinal products, if appropriate;
5.10. Name or corporate name and permanent address of the manufacturer and name or corporate
name and permanent address of the applicant, if requested;
5.11. Supply classification of medicinal product specified by the Center according to the criteria
approved by MoH Ukraine;
5.12. Date when the package leaflet was reviewed for the last time;
5.13. For radiopharmaceuticals, full details of internal radiation dosimetry, additional detailed
instructions for extemporaneous preparation and quality control of such preparation and, where
appropriate, maximum storage time during which any intermediate preparation such as an eluate
or the ready-to-use pharmaceutical will conform with its specifications.
Besides, a package leaflet for radiopharmaceuticals shall describe all precautions, which are to
be followed by medical staff and patients during preparation and use of medicinal product, and
also special precautions for utilization of package or its non-used content.
6. Summary of product characteristics*(SPС) shall contain the following information:
6.1. Name of medicinal product together with the strength and pharmaceutical form.
6.2. Qualitative and quantitative composition in terms of the active substances and constituents
of the excipient, knowledge of which is essential for proper administration of the medicinal
product. The usual common name or chemical description shall be used.
6.3. Pharmaceutical form.
6.4. Clinical particulars:
6.4.1. Therapeutic indications.
6.4.2. Posology and method of application for adults and, where necessary for children,
6.4.3. Contraindications,
6.4.4. Special warnings and precautions for use and, in case of immunological medicinal
products, any special precautions to be taken by persons handling such products and
administering them to patients, together with any precautions to be taken by the patient.
6.4.5. Interaction with other medicinal products and other forms of interactions.
6.4.6. Use during pregnancy and lactation.
6.4.7. Effects on ability to drive and to operate other automated machines.
6.4.8. Side effects.
6.4.9. Overdose (symptoms, emergency procedures, antidotes).
6.5. Pharmacological properties:
6.5.1. Pharmacodynamic properties,
6.5.2. Pharmacokinetic properties,
6.5.3. Preclinical safety data.
6.6. Pharmaceutical particulars:
6.6.1. List of excipients,
6.6.2. Major incompatibilities.
6.6.3. Shelf life, when necessary after reconstitution of the medicinal product or when the
immediate packaging is opened for the first time.
6.6.4. Special precautions for storage.
6.6.5. Nature and contents of primary packaging.
6.6.6. Special precautions for disposal of a used medicinal product or waste materials derived
from such medicinal product, if appropriate.
6.7. Registration certificate holder.
6.8. Registration certificate number(s).
6.9. Date of the first registration or re-registration.
6.10. Date of revision of the SPC’s text.
6.11. For radiopharmaceuticals, full details of internal radiation dosimetry.
6.12. For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation
and quality control of such preparation and, where appropriate, maximum storage time during
which any intermediate preparation such as an eluate or the ready-to-use medicinal product will
conform with its specifications.
Summary of product characteristics for a medicinal product shall be approved at Applicant’s
request
*
(Annex 8 amended by MoH Ukraine Order as of 25.09.2008 № 543)