DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 21, 2025 No. 18

About modification of requirements to the instruction on medical application of medicine and general characteristic of medicine for medical application

According to articles 4 and 8 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and Item 98 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission solved:

1. Bring in the requirements to the instruction on medical application of medicine and general characteristic of medicine for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 88, of change according to appendix.

2. Determine that the instruction on medical application of medicine and general characteristic of medicine for the medical application registered according to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78, before entry into force of this Decision shall be brought into accord with this Decision in case of introduction of the first after entry into force of this Solution of the changes requiring examination in the instruction on medical application of medicine and (or) general characteristic of medicine for medical application.

3. This Decision becomes effective after 30 calendar days from the date of its official publication, except for Item 2, which becomes effective after 180 calendar days from the date of official publication of this Decision.

Members of council of the Eurasian economic commission:

From the Republic of Armenia

M. Grigoryan

From the Republic of Belarus

I. Petrishenko

From the Republic of Kazakhstan

S. Zhumangarin

From the Kyrgyz Republic

D. Amangeldiyev

From the Russian Federation

A. Overchuk

Appendix

to the Decision of Council of the Eurasian economic commission of February 21, 2025 No. 18

The changes made to requirements to the instruction on medical application of medicine and general characteristic of medicine for medical application

1. Requirements to the instruction on medical application of medicine and general characteristic of medicine for medical application to state in the following edition:

"Are approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 88

(in edition of the Decision of Council of the Eurasian economic commission of February 21, 2025 No. 18)

Requirements to the instruction on medical application of medicine and general characteristic of medicine for medical application

I. General provisions

1. The general characteristic of medicine for medical application (further - OHLP) contains the official information on medicine for medical application intended for health workers for the purpose of the correct purpose of medicine and control of its application. Information on medicine in OHLP is subject to approval of state members of the Eurasian Economic Union by authorized bodies (further respectively - state members, the Union) in the field of drug circulation (further - authorized bodies of state members) during registration (registration confirmation (re-registration), modification of the registration file) and the subsequent address of the registered medicine on customs area of the Union. Content of OHLP is allowed to be changed:

from approval of authorized bodies of state members;

the applicant in case of introduction of changes by him in the registration file of medicine according to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 (further - Rules of registration and examination).

2. OHLP is the main source of information for health workers on safe and effective use of medicine. The instruction on medical application of medicine (leaf insert) (further - LV) is constituted according to OHLP.

3. OHLP is not intended for establishment of general recommendations about treatment of separate diseases, however in it specific aspects of treatment and effect of use of medicine shall be specified. OHLP shall not contain general recommendations about procedures of maintaining these or those patients, but at it there shall be specific aspects for purpose of the corresponding medicine.

4. These requirements contain instructions concerning submission of information in OHLP. Information provided in each Section OHLP shall correspond to heading of the Section to which it belongs. It is allowed to specify questions concerning use of medicine more than in one Section OHLP, in such cases it is necessary to make reference to other Sections OHLP in which the relevant additional information is provided.

5. These requirements include:

the instructions concerning precautionary information on content of excipients given in the list according to appendix No. 1;

general and special requirements to OHLP of separate groups of medicines (for example, pegylated proteins, vaccines, lines of dosages of the medicines, homeopathic medicines or medicines received from blood or plasma of blood) according to appendices No. 2, 3, 8, 13 and 19;

special requirements for information statement in separate Sections OHLP (formulations of names of groups of undesirable reactions, instructions for use of medicines at pregnancy and lactation, formulations of storage conditions, specifying of expiration dates (storage durations) of sterile medicines after manipulations with them, instructions of dosages of medicines) according to appendices No. 4 - 7 and 9;

examples of the OHLP and LV templates and procedure for their filling according to appendices No. 10 - 12, 15 - 16;

the instructions for ensuring legibility of information on medicine and its assessment when conducting the user testing given in appendices No. 14, 17 and 18.

6. As a rule, separate OHLP for each dosage form, and in certain cases and for each dosage is required. Preparation of single OHLP for several dosage forms and (or) dosages is performed when the scheme of acceptance of medicine provides change of the mode of dosing or method of application of the used dosage form in the course of treatment.

7. OHLP is placed in the unified register of the registered medicines, and also placement of OHLP on the official site of authorized body (the expert organization) of state member on the Internet is allowed (further - the Internet).

II. Submission of information on medicine, and also questions, the concerning creation (changes), examinations and approvals of information on medicine

8. Information containing in OHLP and LV shall be provided in accurate and laconic form. OHLP and LV join in the module of 1 registration file. In case of failure to meet requirements, the OHLP shown to creation and (or) LV and specified in Items 13, 15 and 16 for original medicine in Items 13 and 15, the subitem "an" of Item 17 of these requirements - for reproduced, hybrid, biosimilar medicines (biosimilar), the registration file of such medicine or the amendment to documents of the registration file are recognized incomplete, and term on representation of missing materials of the registration file according to notes of authorized body (the expert organization) of the reference state is represented to the applicant provided by Rules of registration and examination.

9. Each Section OHLP and LV shall begin with information relating to the primary target group of patients for whom medicine intends, and if necessary it shall be supplemented with specific information on separate groups of patients (for example, children or elderly people). If medicine is intended for the single target group "adult patients", it is not obligatory to specify it in each Section.

10. In OHLP medical terminology shall be used.

11. OHLP contains information on specific medicine therefore it shall not include references to other medicines, except as specified, when it is the caution recommended by authorized body (the expert organization) of state member and also if medicine needs to be accepted according to the scheme exclusively in total with other medicines.

12. Provisions of these requirements are applied to all medicines. Application of the specified provisions for specific medicine also depends on scientific medical data on medicine and conditions of its registration. The variation from these requirements needs to be proved in the summary of the module 2 registration files.

13. For conducting examination the OHLP and LV projects prepared according to these requirements including according to appendix No. 12 to these requirements are represented in the PDF format with the recognized text (including in the PDF format with possibility of editing. Representation in the Word format is in addition allowed).

14. During conducting examination of OHLP and LV for complete and correct reflection of notes experts of authorized bodies (the expert organizations) of state members have the right to make corrections in the reviewing mode to the OHLP and LV projects provided by the applicant.

15. The OHLP and LV complete projects with the changes made in the reviewing mode are intended for ensuring traceability of all changes made to them. The OHLP and LV complete projects which are exclusively approved by results of modification are subject to approval. The applicant needs to prove with use of scientific medical data all made changes in OHLP and (or) LV, except for changes of editorial nature.

16. In case of modification of the text of OHLP and (or) LV the holder of the registration certificate of original medicine shall include in the module of 1 registration file:

a) OHLP and LV approved in the manufacturing country;

b) OHLP and LV approved in the country holder of the registration certificate of medicine in case of impossibility of accomplishment of provisions of the subitem "an" of this Item;

c) OHLP and LV approved in other country of the region of the International council on harmonization of technical requirements to pharmaceutical medicines for medical application (ICH) where medicine is registered (in the presence) in case of impossibility of accomplishment of provisions of subitems "an" and "b" of this Item.

17. In case of modification of the text of OHLP and LV for the reproduced, hybrid and biosimilar (biosimilar) medicines the following special requirements are established:

a) the holder of the registration certificate of the reproduced, hybrid or biosimilar (biosimilar) medicine shall provide:

OHLP and LV of original (reference) medicine (in the presence) operating in the manufacturing country, and (or) the country holder of the registration certificate, and (or) the country of the region of the International council on harmonization of technical requirements to pharmaceutical medicines for medical application (ICH) in state language of the state in which they are approved (with transfer into Russian);

the declaration that in the OHLP and LV projects of the reproduced, hybrid or biosimilar (biosimilar) medicine there are no differences from the differences operating with OHLP and LV of original (reference) medicine, except for which are marked out and proved according to requirements of the paragraph of the fourth this subitem; line-by-line (located in parallel on one leaf) comparison by existing OHLP and LV of original (reference) medicine and the OHLP and LV projects of the reproduced, hybrid or biosimilar (biosimilar) medicine with allocation and reasons for all differences. Distinctions in producers, expiration date (storage duration), composition of excipients, insignificant distinctions in bioavailability or pharmacokinetics, and also distinctions in connection with restrictions, stipulated by the legislation state members in the field of protection of copyright and related rights belong to typical distinctions. Availability of other distinctions if they are evidence-based is allowed. Distinctions available of the line of break (risks) allowing to divide divisible dosage form into equal shares will not always be insignificant as they can affect possibility of achievement of the mode of the dosing given in OHLP of original (reference) medicine considerably;

b) if after registration of the reproduced, hybrid or biosimilar (biosimilar) medicine changes are made to OHLP and (or) LV of the corresponding original (reference) medicine, the holder of the registration certificate of the reproduced, hybrid or biosimilar (biosimilar) medicine shall within 120 working days from the date of the publication in the unified register of the registered OHLP and LV medicines of original (reference) medicine to make corresponding changes to OHLP and (or) LV of such reproduced, hybrid or biosimilar (biosimilar) medicine taking into account the differences specified in paragraph four of the subitem "a". In case of failure to meet requirements of this subitem concerning such reproduced, hybrid or biosimilar (biosimilar) medicine according to the Section X of Rules of registration and examination the authorized body of state member suspends, withdraws (cancels) the registration certificate or limits application or sends to the holder of the registration certificate of the reproduced, hybrid or biosimilar (biosimilar) medicine the requirement about modification of the relevant documents of the registration file with indication of the term of accomplishment of such requirement;

c) if during examination of the registration file of the reproduced, hybrid or biosimilar (biosimilar) medicine (within registration confirmation (re-registration), reduction of the registration file of the medicine registered according to the national procedure in state members in compliance with Rules of registration and examination, modification of the registration file) it is revealed that the editorial office OHLP and (or) LV operating within the Union or in one of state members of original (reference) medicine does not correspond to up-to-date data by efficiency and safety of medicine (including the conclusions of examinations and the recommendation of authorized bodies in the field of drug circulation of the third countries) or does not correspond to OHLP and (or) LV approved in the manufacturing country or the country holder of the registration certificate of medicine the following operations are performed: the authorized body (the expert organization) of state member creates request to the holder of the registration certificate of the corresponding original (reference) medicine about need of correction of OHLP and (or) LV of such medicine and sends it to the authorized body (the expert organization) of the reference state which registered this medicine;

conducting examination of the registration file of the reproduced, hybrid or biosimilar (biosimilar) medicine stops;

the authorized body (the expert organization) of the reference state within 5 working days from the date of receipt of request from authorized body (the expert organization) sends the specified inquiry to the holder of the registration certificate of the corresponding original (reference) medicine;

the holder of the registration certificate of the corresponding original (reference) medicine within 40 working days from the date of receipt of request gives to the authorized body (the expert organization) of state member which sent the specified inquiry, the statement for modification of the registration file of such original (reference) medicine taking into account the requirements and (or) recommendations containing in the received request or represents written reasons for lack of need of introduction of such changes.

Based on the written reasons provided by the holder of the registration certificate, the authorized body of state member which sent inquiry within 20 working days from the date of receipt of the specified reasons withdraws or confirms the requirement about modification of OHLP and (or) LV. If the requirements specified in primary request are confirmed by the authorized body of state member which sent inquiry, or they are adjusted taking into account the explanations provided by the holder of the registration certificate, modification of the registration file of the registered original (reference) medicine is performed according to Rules of registration and examination;

after approval of OHLP and (or) LV of original (reference) medicine according to the specified procedure examination of the registration file of the reproduced, hybrid or biosimilar (biosimilar) medicine is resumed. At the same time the request specified in the paragraph the second this subitem is not considered as request to the holder of the registration certificate of the reproduced, hybrid or biosimilar (biosimilar) medicine.

Due to possibility of initiation by authorized body of state member of the specified procedure, the applicant should not group modification of the operating OHLP and (or) LV of the reproduced, hybrid or biosimilar (biosimilar) medicine with other types of changes;

d) if the holder of the registration certificate of original (reference) medicine within 40 working days from the date of receipt of request, according to the paragraph to the fifth the subitem "v" of this Item, does not submit the statement for modification of the registration file of such original (reference) medicine to authorized body (the expert organization) of state member or does not represent written reasons for lack of need of introduction of such changes, relevant provisions of Rules of registration and examination about action suspension, withdrawal (cancellation) of the registration certificate of medicine, either application restriction, or modification of conditions of action of the registration certificate are applied. In this case examination of the registration file of the reproduced, hybrid or biosimilar (biosimilar) medicine is performed without irrelevant OHLP and (or) LV of original (reference) medicine;

e) if the situation specified in the subitem "v" of this Item arises in case of registration of the reproduced, hybrid or biosimilar (biosimilar) medicine, examination of the registration file of such medicine does not stop, and requirements of the subitem "an" of this Item are applied. The authorized body (the expert organization) of state member initiates the procedure of modification of the registration file of the corresponding original (reference) medicine according to provisions of the subitem "v" of this Item.

18. In case of detection of discrepancy of the operating OHLP and (or) LV of the medicine registered in one of state members, to modern data on efficiency and safety of this medicine (including the conclusions of examinations and the recommendation of authorized bodies in the field of drug circulation of the third countries), including to OHLP and (or) LV approved in the manufacturing country or the country holder of the registration certificate of medicine authorized bodies (the expert organizations) of state members or other persons have the right to address to authorized body of state member in which medicine, with initiative about the direction to the holder of the registration certificate of such medicine of request about need of modification of the operating OHLP and (or) LV is registered such medicinal.

19. In case of receipt of the request specified in Item 18 of these requirements the procedure specified in paragraph five of the subitem "v" of Item 17 of these requirements is applied.

20. In case of failure to meet requirements, these requirements specified in Item 19, provisions of the subitem "g" of Item 17 of these requirements are applied.

21. Provisions of Items 19 and 20 of these requirements extend to holders of registration certificates of all medicines registered according to Rules of registration and examination.

22. Approved by authorized bodies of state members of OHLP and LV take place in the unified register of the registered medicines, their placement on the official site of authorized body (the expert organization) of state member on the Internet is also allowed.

23. For the medicines requiring additional monitoring of safety before Section 1 OHLP the special symbol (), accompanied with the following formulation is placed: "This medicine is subject to additional monitoring. It will allow to reveal new information on safety quickly. We appeal to specialists of health care system to report about any suspected undesirable reactions.".

III. Sections OHLP

1. Name of medicine

24. In this Section OHLP the trade name of medicine, data on dosage and dosage form are specified. Further in the text of OHLP of the data on dosage and dosage form in the name of medicine it is allowed not to specify.

Dosage

25. The dosage shall correspond to quantitatively determined content of active ingredient and use of medicine and to match with the amount of active ingredient specified in quantitative structure and the mode of dosing. Different dosages of the same medicine are specified equally (for example, 250 mg, 500 mg, 750 mg). It is necessary to avoid use of decimal dividers, when applicable (for example, 250 mkg, but not 0,25 of mg). If the dosage form is provided by two and more dosages expressed by several units of measure (for example, 250 mkg, 1 mg and 6 mg), then it is in certain cases more reasonable to specify dosage in the same units for the purpose of comparability (for example, 0,25 of mg, 1 mg and 6 mg). For the purpose of safety dimension size "millions", "billions" (for example, units) always should be written completely, but not to reduce. It is not necessary to specify insignificant zero (for example, 3,0 or 2,500).

26. For medicines at which expression of content of active ingredients in units of mass cannot characterize fully biological activity (for example, for biological medicines) the dosage can be expressed in units used in pharmacopeias:

ME - the international unit of biological activity;

Lf - unit of biological activity of toxin (anatoxin);

PFU - plaque-forming units;

Ph. Eur. U. - unit of the European pharmacopeia.

Expression of dosage in other units is allowed, for example:

PIECE - units of action of biological activity;

PNU - units of protein nitrogen.

If the international unit of biological activity was determined by WHO, when specifying activity of medicine it is necessary to apply this unit.

Dosage form

27. The dosage form of medicine needs to be specified according to:

the complete standard term of the Pharmacopoeia of the Eurasian Economic Union approved by the Decision of Board of the Eurasian economic commission of August 11, 2020 No. 100 (further - the Pharmacopoeia of the Union), in plural (when applicable) (for example, tablets);

provisions of Section 3 OHLP.

In the absence of the suitable complete standard term the new term by combination of standard terms according to the Nomenclature of dosage forms approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 No. 172 is constituted.

If it is impossible, the applicant should send the appeal to authorized body of state member about need of introduction of the new standard term by Pharmacopoeian committee of the Eurasian Economic Union. The way of introduction of medicine and primary (internal) package in the address are not specified, except as specified, when these elements are part of the standard term or are necessary for the purpose of safety, or in the presence of identical medicines which are possible for differentiating only by means of specifying of way of introduction or primary (internal) package.

28. The name and dosage of medicinal vegetable medicines shall correspond to acts of bodies of the Union in the field of drug circulation.

2. High-quality and quantitative structure

29. The complete description of high-quality and quantitative composition of medicine concerning active ingredient (active ingredients) is given in this Section. In need of this Section and information on substances which need to be considered as a part of medicine for its correct application is provided in Section 4.3 or 4.4 OHLP. For example, the high-quality composition of the excipients specified in appendix No. 1 to these requirements shall be specified in the form of the phrase "Substances which availability should be considered as a part of medicine:".

At the end of the Section it is necessary to specify the following standard formulation: "The complete list of excipients is provided in Section 6.1.".

If solvent is part of medicine, the information about him needs to be included in appropriate sections of OHLP (for example, 3, 6.1, 6.5 and 6. 6).

High-quality structure

30. The name of active ingredient is provided according to the international non-proprietary name recommended to WHO (further - MNN) and if necessary is supplemented with specifying of salt or hydrated form. In the absence of MNN it is necessary to use the name on the Pharmacopoeia of the Union, and in the absence of such name in the Pharmacopoeia of the Union - the commonly accepted, chemical or grouping name of active ingredient. In the absence of the commonly accepted, chemical or grouping name it is necessary to specify exact scientific designation. For the active ingredients which do not have exact scientific designation it is specified as well as what they are made of. It is not allowed to include references to pharmacopoeian quality.

31. If medicine is medicinal vegetable medicine, specifying of high-quality composition of such medicine is determined according to acts of bodies of the Union in the field of drug circulation.

32. When specifying high-quality composition of the medicine representing radio pharmaceutical set it is necessary to specify that the radioisotope is not part of set.

Quantitative structure

33. The amount of active ingredient needs to be expressed per unit of dosing (in the dosed inhalation medicines - on the delivered dose and (or) the measured dose), per unit of amount or unit of mass, and it shall correspond to the dosage specified in Section 1 OHLP.

34. The amount of active ingredient needs to be expressed by means of the international acknowledged standard term which is supplemented if necessary with other term if it is more clear to health workers.

Salts and hydrates.

If active ingredient is presented in the form of salt or hydrate, the quantitative structure should be expressed in units of mass (or biological activity in international (or others) units, when applicable) to active part of molecule of active pharmaceutical substance (the basis, acid or anhydrous salt) (for example, "60 mg of toremifen (as citrate)" or "toremifena the citrate equivalent to 60 mg of toremifen").

If during preparation of ready medicine in reactionary mix (insitu) salt (for example is formed, when mixing the solvent and powder), it is necessary to reflect quantity of active part of molecule of active ingredient with indication of on formation of insitu salt.

Concerning widely applied active ingredients as a part of medicine which dosage is usually expressed in salt or hydrated form the quantitative structure is allowed to be expressed as amount of salt or hydrate (for example, "60 mg of diltiazem of hydrochloride"). This rule is also applicable if salt is formed by insitu.

Ethers and pro-drugs.

If active ingredient is presented in the form of ether or pro-medicine, the quantitative structure needs to be expressed as amount of ether or pro-medicine.

For medicine - pro-medicine which active part of molecule of active ingredient is registered in the form of independent medicine also equivalent quantity of active part of molecule of active ingredient is specified (for example, "75 mg of fosfenitoin are equivalent to 50 mg of fenitoin").

Powder (granules) for preparation of solution or suspension for intake.

The amount of active ingredient needs to be expressed per unit of dose if medicine is one-dose, or per unit of volume dose after recovery if medicine is multidose. It is in certain cases reasonable to specify molar concentration.

Medicines for parenteral introduction (except for the recovered powders).

If general content of primary (internal) package of one-dose medicines for parenteral introduction is entered in the form of one dose ("complete use of content of primary (internal) package"), the amount of active ingredient should be expressed on release form (for example, 20 mg, etc.) without specifying of excesses and excess. It is necessary to specify amount of active ingredient 1 ml and the total declared amount also.

If the amount of one-dose medicines for parenteral introduction is calculated based on body weight, surface area of body or other variable patient ("partial use of content of primary package"), the amount of active ingredient should be expressed in milliliters. It is necessary to specify also total declared amount. Excesses and excess are not specified.

The amount of active ingredient of multidose parenteral medicines and parenteral medicines in large volumes should be expressed on 1 ml, on 100 ml, on 1000 ml, etc. in compliance with circumstances, except for the multidose vaccines containing "n" of identical doses. In this case the dosage should be expressed on volume dose. Excesses and excess are not specified.

When applicable (for example, concerning the X-ray contrast agents and parenteral medicines containing inorganic salts), the amount of active ingredient should be specified also in миллимолях. For X-ray contrast agents with iodinated active ingredients in addition to amount of active ingredient it is necessary to specify amount of iodine 1 ml.

The powder which is subject to recovery before parenteral introduction.

If medicine is the powder which is subject to recovery before parenteral introduction it is necessary to specify the total quantity of active ingredient containing in primary (internal) package without specifying of excesses and excess, and also quantity 1 ml after recovery on condition of lack of several options of recovery and the different used quantities which lead to formation of different final concentration.

Concentrates.

The amount of active ingredient needs to be expressed as content on 1 ml of concentrate and general content of active ingredient. It is also necessary to include content on 1 ml after recommended cultivation on condition of lack of cultivation of concentrate to different final concentration.

Plasters transdermalny.

It is necessary to specify the following quantitative data:

content of active ingredient in plaster;

the average dose delivered for unit of time;

area of releasing surface.

(For example: "Each plaster of 10 cm2 contains 750 mkg of oestradiol, releasing in 24 hours nominally 25 mkg of oestradiol.").

Multidose firm and soft dosage forms.

The amount of active ingredient needs to be specified whenever possible per unit of dosing, in other cases - 1 g, 100 g or as a percentage in compliance with circumstances.

Biological medicines.

Instruction of dosage.

The amount of active ingredient of biological medicines should be expressed in units of mass, units of biological activity or the international units depending on specific medicine, reflecting the procedure accepted in the Pharmacopoeia of the Union in appropriate cases. Concerning pegylated proteins it is necessary to consider provisions according to appendix No. 2 to these requirements regarding the description of structure pegylated (conjugated) proteins in OHLP.

Active ingredients of biological origin.

It is necessary to describe briefly origin of active ingredient, to specify properties of all cellular systems used in production and, when applicable, use of technology of recombinant DNA using the following formulation: "It is received with use of cages of XXX [on technology of recombinant DNA].".

Examples of the description of origin of active ingredient:

"it is received with use of diploid cells of the person (MRC-5)";

"it is received with use of cages of Escherichia coli on technology of recombinant DNA";

"it is received with use of cages of chicken embryos";

"it is received from donor plasma of the person";

"it is received from urine of the person";

"it is received from blood [animals]";

"it is received from tissue of pancreas of pigs";

"it is received from mucous membrane of intestines of pigs".

Special requirements to normal immunoglobulins.

It is necessary to specify distribution of normal immunoglobulins on the subclasses IgG percentage of general content of IgG. Then the upper bound of content of IgA is specified.

Special requirements to vaccines.

It is necessary to specify content of active ingredient per unit of dosing (for example, ml 0,5). In the presence of adjuvants it is necessary to specify their high-quality and quantitative structure.

It is necessary to list the impurity representing the special importance (for example, ovalbumin in the vaccines received from eggs).

Requirements to the description of pharmaceutical properties of vaccines are given in appendix No. 3 to these requirements.

Medicinal vegetable medicines.

Instruction of quantitative composition of active ingredient in medicinal vegetable medicines is determined according to acts of bodies of the Union in the field of drug circulation.

3. Dosage form

35. The name of dosage form is specified according to the Nomenclature of dosage forms. This term shall match with the term specified in Section 1 OHLP. However, if on primary (internal) package the reduced standard term is used, the term in this Section OHLP reduced in addition is provided in brackets.

In the separate paragraph it is necessary to provide the description of appearance of medicine (color, signs, etc.) and on condition of availability in the registration file of medicine of the relevant confirmatory data of the data on the actual sizes of firm dosage form for intake, for example:

"Tablets.

White, round ploskotsilindrichesky tablets with a diameter of 5 mm with the sign "100" on one party.".

36. If on tablets the line of break (risk) is provided, it is necessary to specify whether the reproduced separation of tablets is confirmed (for example: "The line of break (risk) is intended only for razlamyvaniye for the purpose of simplification of proglatyvaniye, but not for separation into equal doses", "The tablet can be divided into equal doses.".

37. It is necessary to provide data on pH and osmolarity (if necessary).

38. If medicine is subject to recovery before application, in this Section OHLP it is necessary to describe appearance before recovery. Appearance of medicine after recovery needs to be specified in Sections 4.2 and 6.6 OHLP.

4. Clinical data

4.1. Indications to application

39. Indications to application are specified accurately and laconically, and shall reflect target disease or condition with indication of therapy orientation (symptomatic, etiotropic or exerting impact on current or progressing of disease), for prevention (primary or secondary), for diagnostics. When applicable, information on target population, especially in the presence of restrictions for separate categories of patients is specified.

Information on final points of research, as a rule, is not provided.

Indications to application for the purpose of prevention and information on target population are allowed to be specified in general.

40. Results of the subsequent researches specifying the formulation of the registered indications or the information about them are allowed to be included in Section 5.1 OHLP if they do not assume inclusion of the new indication to use of medicine.

41. It is necessary to specify information on compulsory provisions of use of medicine if they are not mentioned in other Sections OHLP, but are significant (for example, about the accompanying dietary measures, changes of conduct of life or the accompanying therapy).

42. It is necessary to specify age groupes to which medicine, with indication of age brackets is shown, for example:

"By X it is shown [to adults, newborns, babies, children, teenagers] aged from X to Y [years, months].".

For the purposes of these requirements children's population is divided into age subgroups:

premature newborns (with indication of gestation term);

full-term newborns (0 - 27 days);

children of chest age and babies (28 days - 23 months);

children (2 - 11 years);

teenagers (of 12 - 18 years).

43. If the indication to use of medicine depends on certain genotype, either gene expression, or certain phenotype, this circumstance needs to be reflected in the indication on application.

4.2. Mode of dosing and method of application

44. In the presence of special medical instructions on use of medicine (including limited leave) this Section OHLP begins with the description of such conditions.

In the presence of special concerns concerning safety it is also necessary to reflect recommended restrictions concerning application conditions (for example, "only for application in treatment and prevention facilities" or "it is necessary to have the suitable resuscitation equipment").

Dosing mode.

It is necessary to specify accurately the dosing mode for each method (way of introduction) and for each indication to application.

When applicable, references to official recommendations are given (for example, on primary vaccination and antibiotics, and also revaccination).

When applicable, for each category (subgroups of population on age, body weight are allocated, surface areas of body are respectively specified recommended doses (for example, in mg, mg/kg, mg/m 2) for dosing interval. Frequency rate of application should be expressed in units of time (for example, 1 or 2 times in day (days) or each 6 hours), in order to avoid confusion it is not necessary to use reducings (for example, "1 r/d, 2 r/d, 1 times/days, 2 times/days").

When applicable, are specified:

maximum recommended one-time, daily and (or) general (course) dose;

need of matching of dose;

standard duration of application and all restrictions on its duration, and also, when applicable, need of gradual decrease in dose or recommendation about application cancellation;

the undertaken measures in case of the omission of one or more doses, or, for example, in case of vomiting after medicine acceptance (recommendations shall be as much as possible exact, considering recommended frequency rate of application and the relevant pharmacokinetic data);

preventive measures in order to avoid development of some undesirable reactions (for example, use of antiemetic medicines) with reference to Section 4.4 OHLP;

communication of acceptance of medicine with acceptance of liquid and food together with the reference to Section 4.5 OHLP in the presence of such communication (for example, bonds with the use of alcoholic beverages, grapefruits or milk);

recommendations about repeated application together with information on necessary intervals between courses of treatment (when applicable);

the interactions requiring special correction of dose with references to other applicable Sections OHLP (for example, Sections 4. 4, 4.5, 4.8, 5.1, 5.2);

in need of the recommendation of inadmissibility of early termination of therapy in case of the frivolous undesirable reaction which is frequent, but the passing or eliminated by means of matching dose.

For specific medicine if this information is significant, it is necessary to specify the following:

"Activity of medicine [the trade name of medicine] is expressed in [to specify the name] units. These units are not interchanged with units used for expression of activity of other medicines with [the name of active ingredient].".

Special groups of patients.

Data on correction of dose or other data concerning the dosing mode at special groups of patients are provided in specially selected Sections. The specified data are located on importance degree, for example, in the relation:

elderly people. Accurately need of correction of dose at any subgroups of elderly people with references to other Sections OHLP containing the specified data is specified (for example, Sections 4. 4, 4. 5, 4.8 or 5.2 OHLP);

patients with renal failure. Recommendations about dosing shall correspond to the ranges of values of biochemical markers of renal failure used in clinical trials and results of these researches as much as possible precisely;

patients with liver failure (according to data on the patients included in researches (for example, "alcoholic cirrhosis"), and the determinations used in these researches (for example, point (class) on scale of Chayld-Pyyu));

patients with certain genotype (with references to other Sections OHLP containing more detailed data (when applicable));

other significant special groups of patients (for example, patients with other associated disease or patients with excessive body weight).

Recommendations about correction of dose (for example, based on observations of clinical symptoms and signs and (or) laboratory data, including concentration of medicine in blood), with references to other Sections OHLP are in certain cases provided (when applicable).

Children.

It is necessary to provide the separate Section "Children" in OHLP. The provided data shall cover all subgroups of children. By preparation of this Section use combinations of formulations for the situations described in this Section.

If medicine is shown to children, recommendations about the mode of dosing are specified for each significant subgroup. Age framework shall reflect ratio assessment "advantage - risk", carried out for each subgroup.

If the dosing mode at adults and children matches, it is enough to specify of it, in addition it is not required to repeat the dosing mode.

It is necessary to specify recommended doses (for example, in mg, mg/kg, mg/m 2) for dosing interval concerning age subgroups to which medicine is shown. Concerning different subgroups specifying of different data on dosing can be required. If necessary it is necessary to provide recommendations of rather premature newborns with indication of more suitable age (for example, gestational or post-menstrual).

Depending on subgroup, clinical these and available dosage forms the dose is expressed proceeding from weight or surface area of body (for example, "to children aged from 2 up to 4 years on 1 mg/kg of body weight 2 times a day").

When applicable, data on time of acceptance of medicine shall consider daily routine of the child (for example, school or dream).

If medicine is shown to children and it is impossible to develop suitable children's dosage form, with reference to Section 4.2 OHLP it is necessary to include detailed instructions on method of receipt of the medicine ex tempore in Section 6.6 OHLP.

Doses and method of application at different subgroups of children are allowed to be represented in the form of the table.

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