FEDERAL LAW OF THE RUSSIAN FEDERATION

of March 7, 2017 No. 25-FZ

About modification of part the second Tax Code of the Russian Federation

Accepted by the State Duma on February 22, 2017

Approved by the Federation Council on March 1, 2017

Article 1

Bring in part the second the Tax Code of the Russian Federation (The Russian Federation Code, 2000, No. 32, the Art. 3340, 3341; 2001, No. 1, Art. 18; No. 33, Art. 3421, 3429; No. 53, Art. 5015; 2002, No. 22, Art. 2026; No. 30, Art. 3027; 2003, No. 1, Art. 2, 6, 10; No. 28, Art. 2886; 2004, No. 27, Art. 2711; No. 31, Art. 3222; No. 34, Art. 3517, 3524; No. 45, Art. 4377; 2005, No. 1, Art. 29, 30; No. 30, Art. 3117, 3118, 3128, 3130; No. 50, Art. 5246; No. 52, Art. 5581; 2006, No. 1, Art. 12; No. 10, Art. 1065; No. 27, Art. 2881; No. 31, Art. 3433, 3436; No. 43, Art. 4412; No. 45, Art. 4628; No. 50, Art. 5279; 2007, No. 1, Art. 7; No. 21, Art. 2461; No. 23, Art. 2691; No. 31, Art. 3991, 4013; No. 45, Art. 5417, 5432; No. 46, Art. 5553, 5554; No. 49, Art. 6045, 6071; 2008, No. 30, Art. 3616; No. 48, Art. 5504, 5519; No. 49, Art. 5749; No. 52, Art. 6218, 6219, 6227, 6236, 6237; 2009, No. 1, Art. 19; No. 29, Art. 3582, 3598, 3625, 3642; No. 30, Art. 3735; No. 48, Art. 5731, 5733, 5737; No. 51, Art. 6155; No. 52, Art. 6450, 6455; 2010, No. 15, Art. 1737, 1746; No. 18, Art. 2145; No. 19, Art. 2291; No. 25, Art. 3070; No. 28, Art. 3553; No. 31, Art. 4198; No. 32, Art. 4298; No. 40, Art. 4969; No. 45, Art. 5756; No. 46, Art. 5918; No. 48, Art. 6247, 6250; No. 49, Art. 6409; 2011, No. 1, Art. 7; No. 17, Art. 2318; No. 27, Art. 3873, 3881; No. 29, Art. 4291; No. 30, Art. 4566, 4575, 4583, 4587, 4593; No. 45, Art. 6335; No. 47, Art. 6608; No. 48, Art. 6731; No. 49, Art. 7014, 7016, 7061, 7063; No. 50, Art. 7347, 7359; 2012, No. 18, Art. 2128; No. 24, Art. 3066; No. 29, Art. 3980; No. 31, Art. 4319, 4322, 4334; No. 41, Art. 5526; No. 49, Art. 6748, 6750, 6751; No. 50, Art. 6958; No. 53, Art. 7578, 7584, 7596, 7607, 7619; 2013, No. 9, Art. 874; No. 14, Art. 1647; No. 23, Art. 2866, 2889; No. 30, Art. 4031, 4048, 4049, 4084; No. 40, Art. 5038; No. 44, Art. 5645; No. 48, Art. 6165; No. 52, Art. 6981, 6985; 2014, No. 16, Art. 1835; No. 23, Art. 2936, 2938; No. 26, Art. 3404; No. 30, Art. 4220, 4222; No. 43, Art. 5796; No. 45, Art. 6159; No. 48, Art. 6647, 6662, 6663; 2015, No. 1, Art. 11, 17, 32, 33; No. 10, Art. 1393; No. 14, Art. 2023; No. 18, Art. 2615; No. 27, Art. 3948, 3968; No. 48, Art. 6684, 6689, 6692; 2016, No. 1, Art. 6; No. 6, Art. 763; No. 7, Art. 907; No. 10, Art. 1322; No. 11, Art. 1480, 1489; No. 15, Art. 2061, 2063; No. 23, Art. 3298; No. 26, Art. 3856; No. 27, Art. 4161, 4175, 4178, 4179, 4181; No. 49, Art. 6844, 6845, 6847, 6850, 6851; 2017, No. 1, Art. 4) following changes:

The paragraph the fourth the subitem 1 of Item 2 of Article 149 to state 1) in the following edition:

"medical products. Provisions of this paragraph are applied in case of submission to tax authority of the registration certificate of the medical product issued according to the right of the Eurasian Economic Union or till December 31, 2021 the registration certificate on medical product (the registration certificate on product of the medical appointment (medical equipment) issued in accordance with the legislation of the Russian Federation;";

The paragraph third the subitem 4 of Item 2 of Article 164 to state 2) in the following edition:

"medical products, except for medical products which transactions on realization are exempted from the taxation according to the subitem 1 of Item 2 of article 149 of this Code. Provisions of this paragraph are applied in case of submission to tax authority of the registration certificate of the medical product issued according to the right of the Eurasian Economic Union or till December 31, 2021 the registration certificate on medical product (the registration certificate on product of the medical appointment (medical equipment) issued in accordance with the legislation of the Russian Federation;";

3) the paragraph third the subitem 2 of Item 1 of Article 181 after the words "State Register of Medicines" to add with the words "medicines for medical application for the purpose of forming of the total market of medicines within the Eurasian Economic Union, data on which contain in the unified register of the registered medicines of the Eurasian Economic Union;

4) in Article 333.32.1:

a) state the name in the following edition:

"Article 333.32.1. The amount of the state tax for making of actions by authorized federal executive body when implementing state registration of medicines and registration of medicines for medical application for the purpose of forming of the total market of medicines within the Eurasian Economic Union";

b) the paragraph one to state in the following edition:

"1. Authorized federal executive body of the actions connected with implementation of state registration of medicines according to the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" the state fee is paid for making in the following sizes (depending on types of the performed actions):";

c) add with Item 2 following of content:

"2. For making by authorized federal executive body of the actions connected with implementation of registration of medicines for medical application for the purpose of forming of the total market of medicines within the Eurasian Economic Union according to the right of the Eurasian Economic Union, the state fee is paid in the following sizes (depending on types of the performed actions):

1) for conducting examination of medicine for medical application in case of its registration - 325 000 rubles;

2) for assessment of the expert valuation report of safety, efficiency and quality of medicine for medical application - 325 000 rubles;

3) for conducting examination of medicine with well studied medical application in case of its registration - 45 000 rubles;

4) for assessment of the expert valuation report of safety, efficiency and quality of medicine with well studied medical application in case of its registration - 45 000 rubles;

5) for registration confirmation of medicine for medical application - 145 000 rubles;

6) for entering into the documents containing in the registration file of the registered medicine for medical application, the changes requiring conducting examination of medicine for medical application - 75 000 rubles;

7) for entering into the documents containing in the registration file of the registered medicine for medical application, the changes which are not requiring conducting examination of medicine for medical application - 5 000 rubles;

8) for reduction of the registration file of medicine for medical application in compliance with requirements of the Eurasian Economic Union - 75 000 rubles;

9) for issue of the registration certificate of medicine for medical application - 10 000 rubles;

10) for issue of the duplicate of the registration certificate of medicine for medical application - 2 000 rubles.";

Article 333.32.2 to state 5) in the following edition:

"Article 333.32.2. The amount of the state tax for making of actions by authorized federal executive body when implementing state registration of medical products and registration of the medical products intended for the address in the total market of medical products within the Eurasian Economic Union

1. Authorized federal executive body of the actions connected with implementation of state registration of medical products according to the Federal Law of November 21, 2011 No. 323-FZ "About bases of protection of public health in the Russian Federation" the state fee is paid for making in the following sizes:

1) for issue of the registration certificate on medical product - 7 000 rubles;

2) for conducting examination of quality, efficiency and safety of medical product (depending on class of potential risk of its application according to the nomenclature classification of medical products approved by the federal executive body performing functions on development and realization of state policy and normative legal regulation in the field of health care) in case of its state registration:

class 1 - 45 000 rubles;

class 2a - 65 000 rubles;

class 2b - 85 000 rubles;

class 3 - 115 000 rubles;

3) for entering into the documents containing in the registration file of medical product, the changes which are not requiring conducting examination of quality, efficiency and safety of medical product - 1 500 rubles;

4) for conducting examination of quality, efficiency and safety of medical product (depending on class of potential risk of its application according to the nomenclature classification of medical products approved by the federal executive body performing functions on development and realization of state policy and normative legal regulation in the field of health care) in case of modification of the documents containing in the registration file of medical product:

class 1 - 20 000 rubles;

class 2a - 30 000 rubles;

class 2b - 40 000 rubles;

class 3 - 55 000 rubles;

5) for issue of the duplicate of the registration certificate on medical product - 1 500 rubles.

2. For making by authorized federal executive body of the actions connected with implementation of registration of the medical products intended for the address in the total market of medical products within the Eurasian Economic Union according to the right of the Eurasian Economic Union, the state fee is paid in the following sizes:

1) for issue of the registration certificate of medical product - 7 000 rubles;

2) for conducting examination of safety, quality and efficiency of medical product (depending on class of potential risk of its application according to the right of the Eurasian Economic Union) in case of its registration:

class 1 - 45 000 rubles;

class 2a - 65 000 rubles;

class 2b - 85 000 rubles;

class 3 - 115 000 rubles;

3) for entering into the documents containing in the registration file of medical product, the changes which are not requiring conducting examination of safety, quality and efficiency of medical product - 1 500 rubles;

4) for conducting examination of safety, quality and efficiency of medical product (depending on class of potential risk of its application according to the right of the Eurasian Economic Union) in case of modification of the documents containing in the registration file of medical product:

class 1 - 20 000 rubles;

class 2a - 30 000 rubles;

class 2b - 40 000 rubles;

class 3 - 55 000 rubles;

5) for issue of the duplicate of the registration certificate of medical product - 1 500 rubles;

6) for approval of the expert opinion on assessment of safety, efficiency and quality of medical product in case of its registration (depending on class of potential risk of its application according to the right of the Eurasian Economic Union):

class 1 - 45 000 rubles;

class 2a - 65 000 rubles;

class 2b - 85 000 rubles;

class 3 - 115 000 rubles;

7) for approval of the expert opinion on assessment of safety, efficiency and quality of medical product in case of modification of the documents containing in the registration file of medical product (depending on class of potential risk of its application according to the right of the Eurasian Economic Union):

class 1 - 20 000 rubles;

class 2a - 30 000 rubles;

class 2b - 40 000 rubles;

class 3 - 55 000 rubles.";

To add 6) with Article 333.32.3 of the following content:

"Article 333.32.3. The amount of the state tax for making of actions by authorized federal executive body when implementing state registration of biomedical cellular products

Authorized federal executive body of the actions connected with implementation of state registration of biomedical cellular products according to the Federal Law of June 23, 2016 No. 180-FZ "About biomedical cellular products" the state fee is paid for making in the following sizes (depending on types of the performed actions):

1) for conducting examination of quality of biomedical cellular product, examination of documents for receipt of permission to performing clinical trial of biomedical cellular product and ethical examination of possibility of performing clinical trial of biomedical cellular product in case of the request for state registration of biomedical cellular product - 200 000 rubles;

2) for conducting examination of efficiency of biomedical cellular product and examination of the attitude of the expected advantage towards possible risk of application of biomedical cellular product in case of state registration of biomedical cellular product - 50 000 rubles;

3) for conducting examination of efficiency of biomedical cellular product and examination of the attitude of the expected advantage towards possible risk of application of biomedical cellular product concerning which the international multicenter clinical trials, part from which is carried out in the Russian Federation, are conducted, in case of the request for state registration of biomedical cellular product - 200 000 rubles;

4) for issue of permission to performing clinical trial of biomedical cellular product - 5 000 rubles;

5) for issue of the registration certificate of biomedical cellular product - 5 000 rubles;

6) for issue of the duplicate of the registration certificate of biomedical cellular product - 5 000 rubles;

7) for confirmation of state registration of biomedical cellular product - 50 000 rubles;

8) for entering into the documents containing in the registration file on the registered biomedical cellular product, the changes requiring conducting biomedical examination of biomedical cellular product - 75 000 rubles;

9) for entering into the documents containing in the registration file on the registered biomedical cellular product, the changes which are not requiring conducting biomedical examination of biomedical cellular product - 5 000 rubles;

10) for issue of permission to performing the international multicenter clinical trial of biomedical cellular product - 100 000 rubles;

11) for issue of permission to performing post-registration clinical trial of biomedical cellular product - 100 000 rubles.".

Article 2

1. This Federal Law becomes effective after one month from the date of its official publication, except for Items 1, 2 and 3 articles 1 of this Federal Law.

2. Items 1, 2 and 3 articles 1 of this Federal Law become effective after one month from the date of its official publication and not earlier than the 1st of the next tax period on the corresponding tax.

 

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