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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of November 15, 2017 No. 1380

About features of the description of the medicines for medical application which are subject to purchase for ensuring the state and municipal needs

According to part 5 of article 33 of the Federal law "About Contractual System in the Sphere of Purchases of Goods, Works, Services for Ensuring the State and Municipal Needs" Government of the Russian Federation decides:

1. Approve the enclosed features of the description of the medicines for medical application which are subject to purchase for ensuring the state and municipal needs.

2. To give to the Ministry of Health of the Russian Federation, the Ministry of Finance of the Russian Federation and Federal Antimonopoly Service in need of explanation on application of the document approved by this resolution.

3. This resolution becomes effective since January 1, 2018.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of November 15, 2017 No. 1380

Features of the description of the medicines for medical application which are subject to purchase for ensuring the state and municipal needs

1. This document establishes features of the description of the medicines for medical application which are subject to purchase for ensuring the state and municipal needs (further - medicines), in documentation on purchase of medicines when implementing such purchases (further respectively - documentation on purchase, purchase).

2. In case of the description in documentation on purchase customers in addition to data, stipulated in Item 6 parts 1 of article 33 of the Federal law "About Contractual System in the Sphere of Purchases of Goods, Works, Services for Ensuring the State and Municipal Needs", specify:

a) dosage form of medicine, including including equivalent dosage forms, except for descriptions of dosage form and its characteristics containing in instructions for use of medicines and specifying the specific producer (for example, the description of color, form, taste, etc.);

b) medicine dosage with supply capacity of medicine in multiple dosage and double quantity (for example, when purchasing tablet with dosage of 300 mg in documentation on purchase it is specified: 1 tablet with dosage 300 mg or 2 tablets with dosage of 150 mg), and also with supply capacity of medicine in not multiple equivalent dosages allowing to reach identical therapeutic effect (for example, mg 2,5 bottles, either 3 mg, or mg 3,5), is allowed specifying of concentration of medicine without frequency rate establishment;

c) the residual expiration date of medicine expressed in time units of measure (for example, "not earlier than January 1, 2020" or "at least 12 months from the date of the conclusion of the contract", etc.).

3. In case of the description of subject to purchase in the relation:

a) medicines in cartridges or in other forms of release compatible to devices of introduction (application), - there shall be specifying on supply capacity of medicines with condition of voluntary conveyance to patients of compatible devices of introduction in the quantity corresponding to the number of patients for whose providing medicines in cartridges are bought;

b) the multicomponent (combined) medicines representing combination of 2 or more active agents (that is the active agents which are part of the combined medicine and registered as a part of unicomponent medicines), and also sets of the registered medicines - there shall be specifying on supply capacity of unicomponent medicines;

c) medicines for which requirements to their picking by the solvent or the device for cultivation and introduction of medicine can be established and also to availability of tools for opening of ampoules (for example, files), - there shall be specifying on supply capacity of separate components of such picking;

d) medicines in release forms: "syringe", "the prefilled syringe", "syringe tube", "syringe handle" - there shall be specifying on supply capacity of medicine with the introduction device corresponding to amount of the injected medicine (for example, when purchasing of the prefilled syringe by amount of 1 ml the release form "ampoule" with delivery of the syringe in amount of 1 ml or 2 ml can be specified), except as specified when documentation on purchase contains reasons for need of purchase of medicine of specific form of release.

4. In case of the description of subject to purchase it is allowed concerning medicines:

a) necessary for appointment to the patient in the presence of medical indications (individual intolerance, according to vital indications) according to the decision of the medical commission of the medical organization, - specifying on trade names;

b) intended for parenteral application, - specifying on the way of introduction of medicine (for injections or for infusions);

c) intended only for use in pediatric practice, - specifying on age of the child (from 0, since 3 months, since 12 months, etc.).

5. In case of the description of subject to purchase it is not allowed to specify:

a) the equivalent dosages of medicine providing need of division of firm dosage form of medicine;

b) medicine dosage in certain units of measure in case of possibility of converting in other units of measure (for example, "ME" (the international unit) can be converted into "mg" or "percent" can be converted into "mg/ml", etc.);

c) amount of filling of primary package of medicine, except for solutions for infusions;

d) availability (absence) of excipients;

e) the fixed temperature condition of storage of medicines in the presence of alternative;

e) form of release (primary package) of medicine (for example, "ampoule", "bottle", "blister", etc.);

g) quantity of units (tablets, ampoules) of medicine in secondary package, and also the requirement of delivery of specific number of packagings instead of amount of medicine;

h) requirements to indicators of pharmakodinamika and (or) pharmacokinetics of medicine (for example, time of the beginning of action, manifestation of the maximum effect, duration of effect of medicine);

i) other characteristics of medicines containing in instructions for use of medicines, specifying the specific producer of medicine.

6. The description of subject to purchase may contain specifying on the characteristics provided by subitems "v" - "and" Item 5 of this document if there is no other opportunity to describe medicines. At the same time documentation on purchase shall contain:

a) reasons for need of specifying of such characteristics;

b) the indicators allowing to determine compliance of the purchased medicines to the established characteristics and the maximum and (or) minimum values of such indicators, and also measure values which cannot change.

 

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