4.1. Special procedures
4.1.1. Extension of registration
4.1.1.1. The application for the extension of drug registration must be examined in accordance with the same procedure as the primary drug registration to which it relates.
4.1.1.2. The extension must be registered in accordance with the same procedure as the primary application for drug registration to which it relates, or be included in this drug registration dossier.
4.1.2. Procedure for assigning responsibilities
4.1.2.1. As an exception to paragraph 1.7.1 and sections 2.2 and 2.3, if an minor variation of Type IB, a major variation of Type II or a group of variations in the cases provided for by subparagraph (b) of paragraph 1.7.2, not containing an extension of drug registration, affects several registration dossiers, owned by one holder, the holder of such registration certificates is entitled to adhere to the procedure established in clauses 4.1.2.3-4.1.2.10.
4.1.2.2. For the purposes of paragraphs 4.1.2.3-4.1.2.10, the "reference body" means the authorized body of the Member State concerned, appointed by the expert committee, taking into account the recommendation of the holder.
4.1.2.3. The holder must simultaneously submit to all relevant authorities a statement containing the elements listed in Annex IV, indicating the recommended reference body.
4.1.2.4. If the application meets the requirements specified in clause 4.1.2.3, the expert committee appoints the reference body, and such authority must acknowledge receipt of a valid application.
4.1.2.5. If the selected reference body is an authorized body of the reference state that has not registered all medicinal products affected by the application, the expert committee has the right to require another relevant body to assist the referent body in examining this application.
4.1.2.6. The reference body shall draw up an opinion on the valid statement referred to in paragraph 4.1.2.3 within 60 calendar days from the date of recognition of the receipt of a valid statement with insignificant variations of Type IB type and major variations of Type II.
4.1.2.7. The reference body has the right to shorten the period referred to in paragraph 4.1.2.6, taking into account the urgency of the matter, or to extend it to 90 calendar days in respect of variations in the modification of approved indications for use or inclusion of new indications for use.
4.1.2.8. During the period referred to in paragraph 4.1.2.6, the referent body is entitled to require additional information from the holder of the submission within the time limits established by such a reference body. In this case:
a. the referent body shall notify the remaining relevant authorities of its request for additional information;
b. before the submission of such additional information, the procedure is suspended;
c. The reference body may extend the period referred to in paragraph 4.1.2.6.
4.1.2.9. The reference body should forward its opinion on the valid application to the holder and the other relevant authorities; without limiting the provision to clause 2.6 and within 30 calendar days from the date of receipt of the conclusion, the relevant authorities must approve such an opinion, notify the referring body and correct the registration dossiers in question accordingly.
4.1.2.10. In order to verify the validity of the application and draw up an opinion on the valid application at the request of the reference body, the Member States concerned must provide information relevant to the registration dossier affected.
4.1.3. Pandemic Influenza Situation
4.1.3.1. As an exception to Chapters I, II and III, with proper recognition by the World Health Organization or the EAEU of Pandemic Influenza Situations, relevant authorities are entitled, on an exceptional basis, to temporarily accept variations in the conditions for the registration of a vaccine for the prevention of human influenza in the absence of certain preclinical or clinical data.
4.1.3.2. When accepting a variation in accordance with Part 1, the holder must file the missing preclinical and clinical data within the deadline set by the relevant authority.
4.1.4. Urgent safety restrictions
4.1.4.1. If, at the risk of public health from drugs for medical use, the holder initiates immediate security restrictions on his own initiative, he must immediately notify all relevant authorities of this.
4.1.4.2. If, within 24 hours after the receipt of the information referred to in paragraph 4.1.4.1., the relevant authority does not raise an objection, urgent safety restrictions are deemed to be accepted.
4.1.4.3. If a public health risk arises from the use of medicinal products for medical use, the relevant authorities may impose immediate security restrictions on the holder.
4.1.4.4. If the holder imposes an emergency security restriction or imposes an imposition on it by the relevant body, the holder must submit a relevant variation application within 15 working days from the date of commencement of such restriction.
4.2. Correction of the decision on registration and its implementation
4.2.1. Correction of the decision to register
4.2.1.1. Corrections of the decision on registration based on the results of the procedures stipulated in Sections II and III should be implemented:
a. with major variations of Type II within 60 calendar days after receiving the information mentioned in subparagraph "c" of clause 2.4.1 and subparagraph "a" of clause 3.5.1, subject to the transfer of documents necessary for correcting the registration dossier to the interested member states of the EAEU ;
b. in other cases - within 180 calendar days after receiving the information referred to in subparagraph "c" of clause 2.4.1 and clause "a" of clause 3.5.1, subject to the transfer of documents required for correcting the registration dossier to the interested member states of the EAEU.
4.2.1.2. When correcting the registration decision due to one of the procedures provided for in Sections II, III and IV, the relevant authority must immediately notify the holder of the correction of the decision.
4.2.2. Implementation of variations
4.2.2.1. Realization of minor variations of Type IA is allowed at any time before the completion of the procedure provided for in clauses 2.1 and 3.1.
4.2.2.2. If a notice affecting one or more minor variations of Type IA type is rejected, the holder immediately after receiving the information referred to in subparagraph "a" of paragraph 2.4.1 and subparagraph "a" of paragraph 3.5.1, shall cease the implementation of the considered variation (s).
4.2.2.3. Realization of minor variations of Type IB is allowed only in the following cases:
a. with respect to variations filed in accordance with the procedures provided in Section II, after the notified body of the reference State has notified the holder that it has accepted the notification pursuant to Section 2.2 or if the notice is deemed to have been accepted pursuant to paragraph 2.2.3;
b. with respect to variations filed in accordance with the procedures provided in Section III, after the notified body of the holder has notified that it has accepted the notification pursuant to Section 3.2 or if the notice is deemed to have been accepted pursuant to paragraph 3.2.3;
c. in respect of variations filed in accordance with the procedure provided for in Section 4.2.1, after the notice by the reference body to the holder that the conclusion is positive.
4.2.2.4. Realization of significant variations of type II is allowed only in the following cases:
a. with respect to variations brought in line with the procedures provided in Section II within 30 calendar days from the date of notification by the authorized body of the reference state that the holder has accepted the amendment in accordance with Section 2.3 provided that the documents necessary for correcting the registration dossier are submitted to the interested Member States of the EAEU. If, in accordance with Section 2.6, the approval procedure is initiated, the holder shall not implement the variations until the end of the approval procedure for the variation in question;
b. with respect to variations brought in line with the procedures provided in Section III, after notification by the relevant authority of the holder that it has accepted the amendment under paragraph 3.3;
c. with respect to variations filed in accordance with the procedure provided in clause 4.1.2, within 30 calendar days from the date of notification by the reference body of the holder that the conclusion is positive, provided that the documents necessary for correcting the registration dossier are submitted to the interested Member States of the EAEU if, in accordance with section 2.6 the approval procedure has not been initiated. If, in accordance with section 2.6, the approval procedure is initiated, the holder shall not implement the variation until the approval procedure for acceptance of the variation is completed.
4.2.2.5. The expansion can be implemented only after the relevant body has corrected it or, in case of centralized registration by the Commission, the decision on registration and the corresponding notice to the holder.
4.2.2.6. The implementation of urgent security restrictions and variations affecting security issues may be carried out within the timeframes agreed between the holder and the relevant authority.
4.2.2.7. As an exception to paragraph 4.2.2.6, the implementation of urgent security restrictions and variations affecting safety related to medicinal products registered in accordance with the Rules for Registration and Examination of Medicinal Products within the Eurasian Economic EAEU may be exercised within the time frames agreed between the holder and the authorized body of the reference State, after consultation with the other relevant bodies.