admin – AEM

The tragedy of January 20 was honored at the AEC of MOH

admin — Mon, 20 Jan 2025 05:55:23 +0000

The tragedy of January 20, 1990 in Baku, known as “Black January,” became one of the key moments in the modern history of Azerbaijan, which left a deep mark on the national consciousness of the people. These tragic events, although they were a brutal act of suppressing the aspirations for freedom, played an important role in the formation of national consciousness, the mobilization of the people and the strengthening of the independence of Azerbaijan.

They also influenced subsequent events, including victory in the 44-day war and the return of Karabakh to the country. These prosess are key milestones in the modern history of the country, connected by a common line of struggle for independence, territorial integrity and national identity. Events separated by thirty years reflect the process of national awakening, consolidation and mobilization that shaped the modern Azerbaijani nation.

On January 19, at Analytical Expertise Center of MOH of the Republic of Azerbaijan were honored, the tragedy of January 20 and the martyrs who gave their lives for our independence, which went down in the history of the struggle for freedom and territorial integrity as a heroic page. The AEC’s collective gathered in the assembly hall of the Center honored the Martyrs with a minute of silence. Later, there was a demostration of a documentary film that January 20 is not only a tragedy in the history of Azerbaijan, but also the first peak of the country’s path to independence, the awakening of the desire for freedom of our national ideology, a glorious history when people who lived for many years under the rule of the Soviet empire, raised their voice for freedom and showed courage in the fight for their sovereignty.

We honor with pride!

Results of examination of medical devices

admin — Thu, 20 Jun 2024 08:05:19 +0000

Expert Review of Medical Devices

Aprel

Application form

admin — Thu, 20 Jun 2024 07:55:54 +0000

Application form for examination of medical devices

Legislation

admin — Thu, 20 Jun 2024 07:41:29 +0000

Application for state registration (re-registration) of a medical device and state registration of changes made in the registration documents of a medical device

4.1. State registration (re-registration) of the medical device and state registration of the changes made in the registration documents of the medical device includes the stages of making an application in the manner determined by part 4 of these Rules, conducting the examination by the Institution and issuing the registration certificate to the medical device in the manner determined by Part 7 of these Regulations, in accordance with the “Rule for conducting the examination of medicinal products, including simplified examination” approved by the Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, in accordance with clause 4.4 of these Rules,

4.2. According to Article 1.0.8 of the Law, in order to obtain state registration (re-registration) of medical devices with a higher, high and (or) medium risk level, the following shall be submitted by the applicant to the Ministry together with the application in Appendix No. 1 of these Regulations:

4.2.1. a copy of the document confirming the production right of the manufacturer of the medical device and its annex;

4.2.2. a notarized copy of any of the following documents translated into Azerbaijani:

4.2.2.1. a document confirming the state registration of the medical device in the country where it is manufactured, and if it is not state registered in that country, the document (documents) confirming its state registration in another country (countries);

4.2.2.2. a certificate on free sale or export of a medical device (if any);

4.2.3. a brief description of the fields of application, purpose and component of the medicinal product provided by the manufacturer of the medicinal product;

4.2.4. information on the labeling and packaging of the medical device provided by the manufacturer of the medical device (color models of packaging and labels, content in Azerbaijani);

4.2.5. if the medicinal product provided by the manufacturer contains a medicinal substance, the composition, quantity of that medicinal substance, information on the compatibility of the medicinal substance with medicine;

4.2.6. biosafety information provided by the manufacturer;

4.2.7. a notarized copy of the document provided by the manufacturer containing information on the validation of testing methods and packaging, test results for containing microorganisms (bioburden rate), pyrogenicity and sterility, and process validation in relation to sterile medical devices, translated into Azerbaijani by a notary;

4.2.8. declaration of compliance with the safety and effectiveness requirements of the production of the medical device, indicating the risk level given by the manufacturer;

4.2.9. a copy of the certificate on the quality management system of the production of the medical device issued by the manufacturer;

4.2.10. Documents stipulated in Articles 18.2.1-18.2.3 of the Law of the Republic of Azerbaijan “On Licenses and Permits”.

4.2.11. a copy of the document issued by the manufacturer on the usability of medical devices (in relation to used medical devices).

4.3. Subclauses 4.2.1, 4.2.2, 4.2.8 and 4.2.9 of these Regulations do not apply to medical devices produced in the Republic of Azerbaijan, subsection 4.2.5 does not apply to medical devices used to obtain information by examining samples from the human body in a test tube, subsection 4.2.6 does not apply to medical devices that do not come into contact with the human body.

4.4. If there is information about the medicinal substance in the documents submitted during the state registration of medicinal products prepared in a pharmaceutical form with a certain dose, consisting of natural, synthetic substances and their combinations, in order to determine the quality, effectiveness and safety of the medicinal substances in its composition, before being registered with the state, the “Analytical Expertise Center” public legal entity (hereinafter – the Institution) must be examined.The implementation of this expertise is carried out according to the “Rule for conducting the expertise of medicinal products, including simplified expertise” approved by the Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019.

4.5.. The documents or information that must be attached to the application in clauses 4.2 and 4.3 of these Rules by the institution are obtained in accordance with clause 3.6 of these Rules.

Tracking and Tracing of Medicines Department

admin — Mon, 27 May 2024 13:38:29 +0000

The Department Tracking and Tracing of Medicines operates as a structural unit of the public legal entity “Analytical Expertise Center” of the Ministry of Health.

In accordance with his duties, he performs the following functions:

Organization of the activities of the medicine tracking and tracing system, continuous development of the system, regular verification of its effectiveness, as well as taking the necessary corrective or preventive measures;
Carrying out tracking and tracing of medicines;
Development of regulatory legal acts on the tracking and tracing of medicines and making proposals to change current legislation;
Determining and conducting relevant trainings for participants in the circulation of medicines on the topic “Tracking and tracing system”;
Perform other duties provided for by law in relation to the system of tracking and tracing of medicines.

General information about the use of the system

The “Tracking and tracing system of medicines” on the territory of the country, as one of the main concepts, is mentioned in Article 1.0.35 of the Law of the Republic of Azerbaijan “On Medicines”.

1.0.35 – “Tracking and tracing system of medicines is an information system that provides control over the import and circulation of medicines, as well as containing information about their production and purpose”

The establishment of a “Tracking and tracing system of medicines” by January 1, 2024, also provides for the Law of the Azerbaijan Republic dated July 14, 2023 No. 979-VIQD “On Amendments to the Law of the Azerbaijan Republic “On Medicines” and on the application of the Law of the Azerbaijan Republic “On medicines” of the President of the Azerbaijan Republic dated February 6, 2007 “On amendments to the Decree of the President of the Azerbaijan Republic No. 528” dated August 15, 2023 No. 2298, paragraph 3.2.

Providing real-time monitoring of all stages from the production or import of medicines to their delivery to the final consumer, in order to ensure the safety of the circulation of medicines and prevent their smuggling, the “Tracking and tracing system of medicines” will be gradually implemented from January 1, 2024.

Initially, tracking of psychotropic and potent drugs is being carried out throughout the country. At the next stage of implementation of the system, monitoring of other medicines will be launched in the warehouses of all local manufacturing companies and importers, as well as in real time in medical institutions and pharmacies.

“Tracking and tracing system of medicines” is an information web platform developed by the Turkish company “TCHealth” commissioned by the Ministry of Health of the Republic of Azerbaijan. This system allows for electronic accounting of coded (branded) medicines in accordance with the GS1 2D Datamatrix standard. Participants in the circulation of medicines log into this System using the appropriate username and password. These user accounts are created on the basis of information provided by the relevant institutions of the “Tracking and Tracing of medicines Department”, which acts as the operator of the System.

Useful links

Web address (link) to access the “Track and trace system of medicines”:

https://dvtis.e-health.gov.az/account/login

How is tracking and tracing system used by pharmaceutical wholesalers?

https://www.youtube.com/embed/i7wccTqc2vc?feature=oembed

How is the “movement” process carried out in the tracking and tracing system of medicines?

https://youtu.be/Eiu0JVOFXPc

How is tracking and tracing system of medicines used by retail pharmaceutical and medical institutions?

https://youtu.be/_vPGBf1bmfw

Contacts:

E-mail: dvtis@pharma.az

Tel: (+99412) 596 – 05 – 20 (252)

(+99450) 246 – 93 – 73

To the ATTENTION of Marketing Authorization Holders!

admin — Mon, 06 May 2024 12:24:15 +0000

The “Analytical Expertise Center” Public Legal Entity of the Ministry of Health of the Republic of Azerbaijan (hereinafter referred to as the Authority), provides information on the list determining the periods and frequency of submission of Periodic Safety Update Reports (PSURs) of medicinal products that have passed state registration in the Azerbaijan Republic.

The “Regulations of the Pharmacovigilance of Medicinal Products” (hereinafter referred to as the Regulations), approved by Decision No. 503 of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, was amended by Decision No. 166 of the Cabinet of Ministers of the Republic of Azerbaijan dated March 18, 2024.

You can familiarize yourself with the amendments made to the Regulations by following the link https://e-qanun.az/framework/44069 on the Unified Electronic Database of Legal Acts of the Ministry of Justice of the Republic of Azerbaijan.

Based on the requirements stipulated in subparagraph 16.2.8 of the Regulations, you can find the periods and frequency of submission of PSURs to the Authority in accordance with the “List of EU Reference Dates and frequency of submission of Periodic Safety Update Reports” for medicinal products, the date of their first state registration in the Azerbaijan Republic, or the international registration date of the medicinal product. This information can be obtained by downloading the Excel document from the below provided link.

(Download Excel file Version No. 6 dated 14.08.2026).

Note: If you have any questions regarding the periods and frequency of PSUR submission to the Authority, you can submit a substantiated official request to the “Bir pəncərə” (Single Window) sector of the Authority.

At the same time, we inform you that if no substantiated official request is made by September 1, 2024, regarding the periods and frequency of PSUR submission to the Authority, the information provided in the table will be considered the basis.

We inform you that if the marketing authorization holders (MAH) do not comply with the requirements of the Regulations in a timely and proper manner, the Authority has the right to take measures in accordance with subparagraphs 19.6 and 19.7 of the Regulations. According to the requirements of these subparagraphs, if non-compliance with the provisions of these Regulations is detected when assessing the compliance of the pharmacovigilance system of the MAH with Good Pharmacovigilance Practice (GVP), the Authority immediately informs the Ministry of Health about such non-compliance. Depending on the nature of the non-compliance specified in subparagraph 19.6 of these Regulations, the Ministry sets a period of not less than 15 (fifteen) days and not more than 3 (three) months for the MAH to eliminate the non-compliance. If the non-compliance is not eliminated within this period and the required documents are not submitted, the state registration of the medicinal product is cancelled.

MD Documents

admin — Tue, 30 Apr 2024 14:32:48 +0000

Documents required for the examination of medical devices produced in pharmaceutical form with a certain dosage, containing substances of natural, synthetic, mineral origin and their complexes

1) Application letter

2) Drug packaging layout design (En/Ru/Tr) (primary and secondary packaging)

3) İnstruction for use (Original (En/Ru/Tr) and AZ)

4) Composition / Ingredient list

5) Certificate of analysis (with methods) (to the presented series)

6) Specification

7) Free Sale certificate

8) Certificate of registration

9) It should be marked on the packaging as a medical device/not a drug – or must have CE/EAC mark in which case Conformita CE or CE declaration must be submitted –

10) Sample -2

Note: Instructions for use and composition document must be submitted in Electronıc format (word). The main and auxiliary items must be the same as the Composition document.

The required documents are submitted to the One Window Service (Bir Pəncərə xidməti) of Analytical Expertise Center.

How to distinguish a fake (counterfeit) Ozempic – PHOTO

admin — Thu, 19 Jan 2023 06:07:23 +0000

In December 2022, we reported on the illegal sale of a limited number of unregistered counterfeit Ozempic MP5B060 medicines in some pharmacies of the country. We provide reliable information based on quality treatment and patient health.

Pharmacies are currently under surveillance. As a result of the measures taken by the Analytical Expertise Center, not a single counterfeit Ozempic was detected over the past week. However, in order to increase patient awareness and prevent similar cases in the future, we once again bring to your attention the distinguishing features of counterfeit and original medicines:

Counterfeit (fake)

Original

Instruction (leaflet): English only

Instruction in two languages: Azerbaijani and English. The leaflet in English is inside the box, the leaflet in Azerbaijani is attached to the box.

Be sure to have a leaflet in Azerbaijani!

Packaging: Labels on the packaging in Arabic

Packing: Inscriptions on the packaging in English

Syringe pen: Numbering of doses up to 80 units in the dosage scale

Pen-Syringe: Doses on the dosage scale are indicated in 3 milligram increments, i.e. 0.25, 0.5 and 1.0.

Country of origin note: Made in Egypt

Country of origin note: Made in Denmark

Happy New Year and World Azerbaijanis Solidarity Day!

admin — Fri, 30 Dec 2022 17:16:50 +0000

Our people, as well as our compatriots living in different countries of the world, celebrate December 31, the Day of Solidarity of World Azerbaijanis, with great excitement and enthusiasm. This holiday is getting bigger and bigger every year. It is a matter of pride for everyone who considers Azerbaijan to be their historical homeland to show solidarity.

It is no coincidence that the Day of Solidarity of Azerbaijanis of the World is celebrated on December 31. The formalization of this date is connected with the name of our national leader Heydar Aliyev. On his initiative, on December 16, 1991, the Supreme Assembly of the Nakhchivan Autonomous Republic adopted a decision to establish the Day of National Solidarity and Unity. Nine days after that, the National Council of the Supreme Soviet of the Republic of Azerbaijan issued an order declaring December 31 as the Day of Solidarity of Azerbaijanis every year. Thus, this date has become a national holiday that Azerbaijanis around the world celebrate with joy every year.

As AEC collective, we heartily congratulate our people on the Day of Solidarity of World Azerbaijanis and the New Year! Strength is together!

Happy Victory Day, Azerbaijan!

admin — Thu, 01 Dec 2022 18:55:44 +0000

Under the leadership of President of the Republic of Azerbaijan, Supreme Commander-in-Chief of the Armed Forces Ilham Aliyev, the Azerbaijani Army has achieved incredible success in the victory march launched on September 27, 2020 to prevent successive provocations and new occupation plans of Armenia and liberate our occupied lands.
As a result of 44 days of military operations, the brave Azerbaijani Army liberated the cities of Jabrayil, Fizuli, Zangilan, Gubadli, Minjivan, Agband, Bartaz settlements of Zangilan region, Hadrut settlement and many villages of Khojavend region, Sugovushan village of Tartar region, several villages of Khojaly and Lachin regions. In total, more than 300 settlements, including important strategic heights in the direction of Aghdara, Murovdagh and Zangilan, were liberated from occupation.
On November 8, after 28 years of longing, the city of Shusha, which is of great importance and symbolic meaning for the people of Azerbaijan, was liberated from occupation. The liberation of Shusha, the crown of Karabakh, was one of the unique military operations in the history of world war.
Azerbaijan’s military victories, especially the liberation of Shusha from enemy occupation, played a decisive role in the fate of the war. All these resulted in Armenia’s recognition of its defeat and capitulation.
By the Order of the President of the Republic of Azerbaijan Ilham Aliyev dated December 3, 2020, it was decided to solemnly celebrate November 8 as Victory Day in the Republic of Azerbaijan every year in order to perpetuate this unprecedented victory, which has become a celebration of the power of our people and our national pride. The staff of Analytical Expertise Center honors the memory of our Martyrs with deep respect and congratulates our people on the Great Victory!