Formation of the application to make changes
on paper and electronic storage 

Submission to the regulatory authority and support
at all stages of the regulatory procedure

 

The registration certificate for a medicine gives the right to use and sell medicines in the Russian Federation. During the registration procedure, the applicant submits data on the medicine to the RF Ministry of Public Health and they, after necessary checks and examinations, are entered into the register.

However, sometimes owners of registration certificates face situations when an existing record of registration needs to be changed. This procedure is carried out in strict accordance with Law No. 61-FZ, it requires the formation and submission of the necessary technical documentation.

 

Cases of making changes

It is possible to amend the existing Registration certificate of a pharmaceutical product in the following cases:
 

  • The owner of the document revealed errors of a technical nature or inaccuracy, which were reflected in the certificate of registration.
  • The company for which the certificate is issued has changed its official name.
  • The firm that owns the identity card has changed its legal address.
  • The owner of the document decided to change the commercial name of the medicine used.
  • The official chemical name of the medicine has changed.
  • The owner of the certificate decided to change the size of the packaging, the completeness of the medicinal product, etc.
  • The requisites (numbers, etc.) of regulatory documents have changed in which the norms regulating the turnover of medicines in the Russian Federation are fixed.

 

Types of changes

According to the current act there are several types of changes:

1. Types 1A and 1B. Changes of a minor nature, which include changing the appearance of the medicine package, text on the box, expanding the scope of application, changing the details of the holder of the certificate, changing the component manufacturers or the owner of the registration document. Produced by re-registration of the certificate.

2. Type 2. Implies changes regarding the safety of use of the drug, correction of the text of the instructions for use, indications and contraindications. In this case, a new registration of the drug.

 

Assistance in preparing documents for making changes

There was a need for changes in the registration certificate? Apply for help to the Center for Clinical Research "Promedika". Our specialists will help with the preparation of the dossier for submission to the state authorities for making changes, as well as will render the following types of services:
 

  • Consultations on the possible consequences of initiating the procedure for introducing changes.
  • Preparation of notarized copies of the required documents.
  • Preparation of application and documentation for changing the registration certificate.
  • Apply to the Ministry of Public Health.
  • Obtaining the corrected registration certificate.

You can contact specialists of the Center "Promedika" by using the feedback on the website or by phone.

 

For the primary analysis (scheme), cost and timing of registration of funds (LS),
Medical products (MI) and dietary supplements according to the rules of the Russian Federation
and the United Arab Emirates the manufacturer must provide the following data:

Medicine

1. Instructions for use


2. Detailed composition


3. Certificate copyGMP


4. Data on pre-clinical and clinical trials


5. The status of product registration in the country of production



Medical product

1. Description of the medical device


2. Copy of ISO certificate, CE certificate (or other similar documents)


3. Data on pre-clinical and clinical trials


4. The status of product registration in the country of production

 



BAA

1.Instructions for use


2. Full composition with percentage of components


3. A copy of the GMP certificate and / or ISO and / or HACCP


4. Data on pre-clinical and clinical trials


5. A copy of the safety certificate for product

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