FEDERAL LAW OF THE RUSSIAN FEDERATION

of January 30, 2024 No. 1-FZ

About introduction of amendments to the Federal law "About Drug Circulation" and articles 1 and 4 of the Federal Law "About introduction of amendments to the Federal law "About Drug Circulation" and the Federal Law "About introduction of amendments to the Federal law "About Drug Circulation"

Accepted by the State Duma on January 18, 2024

Approved by the Federation Council on January 24, 2024

Article 1

Bring in the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; No. 31, Art. 4161; No. 42, Art. 5293; No. 49, Art. 6409; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 11, Art. 1098; No. 43, Art. 5797; No. 52, Art. 7540; 2015, No. 27, Art. 3951; No. 29, Art. 4367, 4388; No. 51, Art. 7245; 2016, No. 23, Art. 3287; No. 27, Art. 4194, 4238; 2017, No. 31, Art. 4791, 4827; 2018, No. 1, Art. 9; No. 24, Art. 3407; No. 49, Art. 7521; 2019, No. 23, Art. 2917; No. 30, Art. 4142; No. 31, Art. 4456; No. 52, Art. 7780, 7793, 7796, 7799; 2020, No. 13, Art. 1856; No. 14, Art. 2028, 2035; No. 29, Art. 4516; No. 50, Art. 8074; No. 52, Art. 8590; 2021, No. 24, Art. 4188; No. 27, Art. 5145; 2022, No. 1, Art. 32; No. 11, Art. 1596; No. 13, Art. 1953; No. 29, Art. 5278; No. 43, Art. 7268; No. 50, Art. 8796; No. 52, Art. 9349; 2023, No. 18, Art. 3248; No. 31, Art. 5767; No. 32, Art. 6160, 6198, 6206; No. 43, Art. 7602) following changes:

Part of 1 Article 1 after words "state registration" to add 1) with the words "according to this Federal Law (further-state registration) or registration according to the international treaties and acts constituting the right of the Eurasian Economic Union (further-registration)";

Part 4 of Article 3 to state 2) in the following edition:

"4. If the international treaty of the Russian Federation, international treaties and acts constituting the right of the Eurasian Economic Union (further - the acts constituting the right of the Union), establish other rules, than those which are provided by this Federal Law are applied the rules of the international treaty, rules containing in the acts constituting the right of the Union.";

3) in Article 4:

a) to add Item 6.1 after the words "for diagnostics" with the word", etiopatogenetichesky";

b) add with Item 6.3 of the following content:

"6. 3) high-technology medicine - the gene therapeutical medicine for medical application, or medicine on the basis of somatic cages for medical application, or tkaneinzhenerny medicine (medicine of fabric engineering);";

c) Item 18 after words "medicinal vegetable raw materials," to add with words of "excipients";

d) add Item 19 with words ", medicinal vegetable raw materials, excipients";

e) state Item 26 in the following edition:

"26) the registration certificate of medicine - the entry in the state register of medicines confirming the fact of state registration of medicine, and (or) the document confirming the fact of state registration (registration) of medicine;";

e) add Item 27 with the words "or registration";

g) to add Item 28 after the words "state registration" with the words "or registration";

h) to add Item 44 after words of "state registration" with the words "or registration";

i) in Item 49 of the word "in writing" shall be replaced with words "in electronic form, signed by the patient (his legal representative) with use of the strengthened qualified digital signature or the simple digital signature by means of application of single system of identification and authentication, and at the request of the patient in writing";

4) in Article 5:

a) in Item 5 of the word "in case of state registration" to exclude;

b) add with Items 7.1 - 7.3 following of content:

"7. 1) registration, registration confirmation (re-registration), modification of the registration file, and also holding the procedures connected with registration according to the rules of registration and examination of medicines for medical application approved by the Eurasian economic commission and regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union;

7. 2) submission of information on registration, registration confirmation (re-registration), modification of the registration file, and also about the procedures connected with registration in the Eurasian economic commission with use of the integrated information system of the Eurasian Economic Union according to approved by the Eurasian economic commission procedure for forming and maintaining the unified register of the registered medicines of the Eurasian Economic Union and regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union;

7. 3) approval of procedure for suspension of action of the registration certificate of medicine or restriction of use of medicine for medical application in the cases provided by the rules of registration and examination of medicines for medical application, and renewal of action of the registration certificate of medicine or lifting of restriction of use of medicine for medical application approved by the Eurasian economic commission;";

c) state Item 8 in the following edition:

"8) the organization and (or) conducting inspection of subjects of drug circulation on compliance to the rules of proper laboratory practice, rules of proper clinical practice, rules of proper distributor practice, rules of proper practice of pharmakonadzor approved by the Eurasian economic commission, and also to rules of proper pharmaceutical practice, storage precautions of medicines approved by authorized federal executive bodies;";

d) state Item 18 in the following edition:

"18) approval of rules of proper pharmaceutical practice, storage precautions of medicines;";

e) to add Item 19 after the words "medicine" with the words "for veterinary application";

e) recognize Items 20 and 21 invalid;

g) in Item 23 of the word "to the instruction on medical application of medicines and" to exclude;

5) in Article 9:

a) to add Item 3 of part 2 after figures "52.1" with figures ", 52.2";

b) add with part 2.1 following of content:

"2.1. For the purpose of ensuring the state control (supervision) in the field of drug circulation the federal executive body performing state registration of medicines provides to the federal executive body performing functions on control and supervision in the field of health care, on its request within interdepartmental information exchange according to the procedure, established by the specified federal executive bodies, the following data on medicines including if such data are trade secret:

1) data on pharmaceutical substance:

a) name of pharmaceutical substance, its structure, general properties;

b) name and address of the producer;

c) properties and structure of active ingredients;

d) characteristic of impurity;

e) the specification on pharmaceutical substance and its reasons;

e) the analytical techniques used in case of control of quality of pharmaceutical substance;

g) analysis results of series of pharmaceutical substance;

h) the list of the standard samples or substances used in case of control of quality of pharmaceutical substance;

i) description of characteristics and properties of packaging materials and corking means;

j) data on stability of pharmaceutical substance;

k) expiration date;

2) data on medicine for medical application:

a) the description and composition of medicine for medical application;

b) description of pharmaceutical development (reasons for the choice of structure, primary package);

c) the name and the address of the place of implementation of production of medicine for medical application (in case of availability of several participants of production process it is necessary to specify the name and the address of each of them);

d) microbiological characteristics;

e) description of characteristics and properties of packaging materials and corking means;

e) quality requirements of excipients;

g) the analytical techniques used in case of control of quality of excipients;

h) data on use of excipients of human and animal origin;

i) data on use of new excipients;

j) quality requirements of medicine for medical application (the certificate, the specification on medicine and their reasons);

k) the analytical techniques used in case of control of quality of medicine for medical application;

l) analysis results of series of medicine for medical application;

m) characteristic of impurity;

o) the list of the standard samples used in case of control of quality of medicine for medical application;

o) data on stability of medicine for medical application;

3) reports on preclinical researches;

4) reports on clinical trials;

5) master file of system of pharmakonadzor;

6) risk management plan.";

c) in part 7:

word in paragraph one of "selective control of quality" shall be replaced with words "federal state control (supervision) in the field of drug circulation";

add with item 4 of the following content:

"4) about removal of medicine from poseriyny selective control of quality of medicines based on the positive expert opinions issued by the federal state budgetary institution subordinated to the federal executive body performing functions on control and supervision in the field of health care, or to the federal executive body performing functions on control and supervision in the field of drug circulation for veterinary application, based on the test report of medicine, carried out on all indicators of the approved regulating documentation (regulating document) concerning three series of medicine.";

The subitem "an" of Item 2 of part 6 of Article 9.1 to add 6) with words ", except for series or batches of the medicines specified regarding the 4th article 52.1 and part 6 of article 52.2 of this Federal Law";

7) in Article 11:

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