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It is registered

Ministry of Justice of Ukraine

August 7, 2003

No. 693/8014

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 29, 2003 No. 358

About approval of form and the description of the registration certificate on medicine

(as amended on 29-07-2024)

According to the Procedure for state registration (re-registration) for medicines, the approved resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376, and for the purpose of display in registration certificates of changes in the registration documents taking place during action of the registration certificate

I ORDER:

1. Approve:

1.1. Form of the registration certificate on medicinal means / medicine (medical immunobiological supply) it (is applied).

1.2. The description of the registration certificate on medicinal means / medicine (medical immunobiological supply) (is attached).

2. The fact of state registration of medicine makes sure the registration certificate on medicine, the fact of state registration of medical immunobiological supply is confirmed by the registration certificate on medicine (medical immunobiological supply).

3. Determine that the registration certificates issued till 15:09. 2003, are valid before the termination of term of their action and do not require exchange.

4. To provide to the director of the MZ State pharmacological center of Ukraine Stefanov O. V.:

4.1. Production of necessary number of forms of registration certificates.

4.2. Provide registration of this order in the Ministry of Justice of Ukraine.

5. Consider invalid the order MZ of Ukraine of 15.05.98 No. 120 "About state registration of medicines", registered in the Ministry of Justice of Ukraine 03.06.98 for No. 362/2802.

6. To impose control of execution of the order on the First Deputy State secretary Pasichnik M. F.

Minister

A. V. Pidayev

Approved by the Order of the Ministry of Health of Ukraine of July 29, 2003 No. 358

Form of the registration certificate on medicinal means / medicine (medical immunobiological supply)

See the Form of the registration certificate on medicinal means / medicine (medical immunobiological supply)

Appendix

to the Registration certificate on medicinal means / medicine (medical immunobiological supplies)

The insert to the registration certificate on medicinal means / medicine (medical immunobiological supplies)

See Appendix (7Kb In original language)

Approved by the Order of the Ministry of Health of Ukraine of July 29, 2003 No. 358

The description of the registration certificate on medicinal means / medicine (medical immunobiological supply)

1. The registration certificate on medicinal means / medicine (medical immunobiological supply) represents the sheet A3 of light blue color compound twice with the mesh drawing. On the periphery of the first page the ornament is represented.

In case of modification of registration documents on medicinal means / medicine (medical immunobiological supply) during action of the registration certificate to the registration certificate on medicinal means / medicine (medical immunobiological supply) the tab (i) is added, it is executed as well as the main pages of the registration certificate. The tab (i) is valid only in the presence of the registration certificate as its integral part.

2. On the left side of the first page of the registration certificate / tab series and number of the form of the registration evidence / tab are put down.

3. In the upper part one of the page of the registration certificate / tab in the center the State Emblem of Ukraine is represented. Under the image of the State Emblem of Ukraine text "MINISTRY OF HEALTH", under it - " Kiev".

On the first page of the registration certificate / tab in the center the holographic sign from below is placed.

On the first page of the form of the registration certificate under the words Kiev" the text "the REGISTRATION CERTIFICATE ON MEDICINAL MEANS / MEDICINE (MEDICAL IMMUNOBIOLOGICAL SUPPLY) No. _____", on tab - "The TAB IN the REGISTRATION CERTIFICATE ON MEDICINAL MEANS / MEDICINE (MEDICAL IMMUNOBIOLOGICAL SUPPLY) No. ______" is made.

On the first page of the registration certificate under text "the REGISTRATION CERTIFICATE ON MEDICINAL MEANS / MEDICINE (MEDICAL IMMUNOBIOLOGICAL SUPPLY) No. _____" is specified "The decision about state ____________________ to registration of medicinal means / medicine (medical immunobiological supply), approved by the order of the Ministry of Health from ______ 20 __ No. ____".

Below the text "According to articles 9, of 9-1 Law of Ukraine "About medicines" is executed and the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376 "About approval of the Procedure for state registration (re-registration) of medicines and the amount of collection for their state registration (re-registration)" medicinal means / medicine (medical immunobiological supply) in Ukraine for a period of ____ / is termless years enforcement of the Law of Ukraine of July 28, 2022 No. 2469-IX "About medicines".

In case of state registration of the medicine which is purchased by person authorized on implementation of purchases in health sector or the medicine which is subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement on agreement performance on purchase between the Ministry of Health and the relevant specialized organization conducting procurement (only for accomplishment of programs and implementation of centralized actions for health care), it is noted that medicinal means / medicine (medical immunobiological supply) is registered in Ukraine before enforcement of the Law of Ukraine of July 28, 2022 No. 2469-IX "About medicines".

Applicant and his location ____________________.

Effective period of the registration certificate in the territory of Ukraine to _ _ _ _ _ _ years / unrestricted enforcement of the Law of Ukraine of July 28, 2022 No. 2469-IX "About medicines" (medicine which is bought by person authorized on implementation of purchases in health sector and also is subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement on agreement performance on purchase between the Ministry of Health and the relevant specialized organization conducting procurement only for accomplishment of programs and implementation of centralized actions for health care).

The registration certificate is drawn up "___" by ____________ 20 __". 

4. In case of execution of the registration certificate after words of "the registration certificate on medicinal means / medicine (medical immunobiological supply)" number of the registration certificate is printed.

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