Inclusion of API in the State Register of Medicines
"Expertise and Inclusion of Pharmaceutical Substance in the State Register of Medicines: Procedure, Requirements, and Timeframes"
To include a pharmaceutical substance intended for commercialization in the State Register of Medicines, an assessment of its quality is conducted.
To conduct the quality assessment of the pharmaceutical substance, the applicant submits to the authorized federal executive body:
1. An application for inclusion of the pharmaceutical substance in the State Register of Medicines.
2. A document confirming payment of the state fee for inclusion of the pharmaceutical substance in the State Register of Medicines.
3. A copy of the license for pharmaceutical production or a copy of the compliance certificate with GMP requirements issued by the authorized federal executive body, if the pharmaceutical product is manufactured in the Russian Federation.
4. A copy of the manufacturing license issued by the authorized body of the manufacturing country, along with its certified translation into Russian, and a copy of the compliance certificate with GMP requirements, if the pharmaceutical product is manufactured outside the Russian Federation.
5. A document containing information about the pharmaceutical substance.
6. A document providing information about the manufacturer’s registration as a taxpayer in the country of registration (for Russian legal entities - taxpayer identification number (TIN); for foreign legal entities - country of registration, name of the registering authority, registration number, taxpayer code in the registration country or its equivalent).
7. An application for permission to import a specific batch of an unregistered pharmaceutical product into the Russian Federation.
The quality assessment of the pharmaceutical substance, preparation of expert conclusions based on the assessment results, and submission to the authorized federal executive body must be completed within no more than sixty working days from the date the expert institution receives the relevant task and documents from the authorized federal executive body.
It is not permitted to include a single pharmaceutical substance, manufactured for commercialization by the same producer, as two or more entries in the State Register of Medicines.
Document containing information about the pharmaceutical substance should include:
a) Name of the pharmaceutical substance, its structure, and general properties;
b) Name and address of the manufacturer;
c) Production technology, detailing production stages and control methods at each production stage;
d) Description of the production process development;
e) Description of control of critical stages of the production process and intermediary products;
f) Documentation confirming process validation or assessment;
g) Properties and structure of active ingredients;
h) Characterization of impurities;
i) Specification for the pharmaceutical substance and its justification;
j) Analytical methods used for quality control of the pharmaceutical substance;
k) Documentation confirming validation of analytical methods used for quality control of the pharmaceutical substance;
l) Results of analysis of batches of the pharmaceutical substance;
m) List of standard samples or substances used for quality control;
n) Description of the characteristics and properties of packaging materials and closures;
o) Stability data of the pharmaceutical substance;
p) Shelf life.
To include a pharmaceutical substance intended for commercialization in the State Register of Medicines, an assessment of its quality is conducted.
To conduct the quality assessment of the pharmaceutical substance, the applicant submits to the authorized federal executive body:
1. An application for inclusion of the pharmaceutical substance in the State Register of Medicines.
2. A document confirming payment of the state fee for inclusion of the pharmaceutical substance in the State Register of Medicines.
3. A copy of the license for pharmaceutical production or a copy of the compliance certificate with GMP requirements issued by the authorized federal executive body, if the pharmaceutical product is manufactured in the Russian Federation.
4. A copy of the manufacturing license issued by the authorized body of the manufacturing country, along with its certified translation into Russian, and a copy of the compliance certificate with GMP requirements, if the pharmaceutical product is manufactured outside the Russian Federation.
5. A document containing information about the pharmaceutical substance.
6. A document providing information about the manufacturer’s registration as a taxpayer in the country of registration (for Russian legal entities - taxpayer identification number (TIN); for foreign legal entities - country of registration, name of the registering authority, registration number, taxpayer code in the registration country or its equivalent).
7. An application for permission to import a specific batch of an unregistered pharmaceutical product into the Russian Federation.
The quality assessment of the pharmaceutical substance, preparation of expert conclusions based on the assessment results, and submission to the authorized federal executive body must be completed within no more than sixty working days from the date the expert institution receives the relevant task and documents from the authorized federal executive body.
It is not permitted to include a single pharmaceutical substance, manufactured for commercialization by the same producer, as two or more entries in the State Register of Medicines.
Document containing information about the pharmaceutical substance should include:
a) Name of the pharmaceutical substance, its structure, and general properties;
b) Name and address of the manufacturer;
c) Production technology, detailing production stages and control methods at each production stage;
d) Description of the production process development;
e) Description of control of critical stages of the production process and intermediary products;
f) Documentation confirming process validation or assessment;
g) Properties and structure of active ingredients;
h) Characterization of impurities;
i) Specification for the pharmaceutical substance and its justification;
j) Analytical methods used for quality control of the pharmaceutical substance;
k) Documentation confirming validation of analytical methods used for quality control of the pharmaceutical substance;
l) Results of analysis of batches of the pharmaceutical substance;
m) List of standard samples or substances used for quality control;
n) Description of the characteristics and properties of packaging materials and closures;
o) Stability data of the pharmaceutical substance;
p) Shelf life.
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