In the section “Biomedical cell products” of our web site there were published a lot of articles, devoted to the analysis of normative documentation and scientific articles related directly or indirectly to the registration of BMCP. This article is devoted to the process of making amendments in the registration dossier for the already registered BMCP.

1. What can be changed?

– Specification for BMCP,

Normative documentation for BMCP (contains the list of quality indicators of BMCP and information about methods of quality control of BMCP, read in details about it in our article “BMCP quality indicators”) [1],

– Designs of primary and secondary packaging for BMCP,

– Manufacturing specification for BMCP,

– Instruction for user of BMCP,

– Name of BMCP,

– Type of BMCP,

– Quality and quantity characteristics of the cell line (s), its name and quantity of excipients in the composition of BMCP,

– Name and quantity of medicinal preparation in the composition of BMCP,

– Name of medical devices (MD) in the composition of BMCP,

– Indications,

– Contraindications,

– Posology and administration of BMCP, duration of treatment,

– Precautions for use of BMCP,

– Indication (if available) of specific features of BMCP action,

– Possible adverse reactions,

– Compatibility with other types of tratement, medicinal preparations, MD, other MD and food,

– Shelf life and indication on prohibiting of BMCP application after termination of validity period,

– Specificity in application in pediatric use, in pregnant women and breastfeeding woman,

– Data about stability of BMCP,

– BMCP storage conditions.

2. When the expertise is required?

– Changes, which are going to be introduced to the instruction for use (see above: Indications – BMCP storage conditions),

– Changing of the factory site address,

– Changes of quality indicators and (or) BMCP methods of quality control, contained in the normative documentation for BMCP (also see above – Changes in normative documentation for BMCP).

3. What documents are required?

– Application for the introduction of changes and changes in the documents in the attachment,

– Documents confirming the necessity of the introduction of changes,

– Documents confirming payments of fees.

4. What is the procedure?

After the dossier submission in 5 working days:

– Checking of data completeness and correctness is conducted

– The decision about expertise is made

– Ministry of Health of the Russian Federation informs the holder of RC about the decision

In this case there 4 possible outcomes:

• Positive decision is made in 30 working days
• Request for the additional information the manufacturer should satisfy the request in 90 working days
• A positive decision about expertise is made:

– Quality expertise of BMCP lasts for 60 working days

– Expertise of BMCP effectiveness lasts for 25 working days

• Negative decision

 

5. How much?

• Introduction of changes in the RC, requiring expertise – 75 000 rubles,
• Introduction of changes in the RU, not requiring expertise – 5 000 rubles,
• Expertise of BMCP quality – 200 000 rubles,
• Expertise of the effectiveness of BMCP and the ratio of expected benefit to the possible risk – 50 000 rubles.

References:

1. ФЗ № 180 «О биомедицинских клеточных продуктах»
2. Приказ Минздрава России от 20.10.2017 № 837н «Об утверждении формы заявления о внесении изменений в документы, содержащиеся в регистрационном досье на зарегистрированный биомедицинский клеточный продукт»
3. Налоговый кодекс Российской Федерации

[1] For the changes in bold biomedical expertise is required.