Notification about technical problem

Dear Colleagues Please be inform you that on 07.12.2022 due to technical problems, the link to the "Database of registered medicines”...

List of documents required for determining the regulatory status of borderline products

To get a conclusion about the type of products (medicines, food supplements, hygiene products or medical products, etc.) it is...

Information about medicines registration

Dear Colleagues. According to the order of the Ministry of Health of the Republic of Armenia N4639-A of October 04, 2022 ...

Order of Minister of Health of the Republic of Armenia N 4639-A of October 04, 2022 «On establishing a temporary procedure for submitting applications for state registration of medicinal products...

Notification of a technical problem to admin@pharm.am

Dear Colleagues We would like to inform you that in 2022 on September 21-23, between 12:00 and 16:30, due to technical...

Decree of the Government of the Republic of Armenia N 715-N of May 16, 2022 on making changes in Decree of the Government of the Republic of Armenia N166-N of...

See hyperlink (File available in armenian) Decree of the Government of the Republic of Armenia N 715-N of May 16, 2022...

Pro-forma invoices of paid services according to the order N 029-A-22 of 14.02.2022

Order on approval of the price list of paid services provided by the Scientific Center of Drug and Medical Technologies Expertise N 029-A-22 of February 14, 2022

http://www.pharm.am/index.php/en/orders/6951-order-on-approval-of-the-price-list-of-paid-services-provided-by-the-scientific-center-of-drug-and-medical-technologies-expertise-n-029-a-22-of-february-14-2022 (index.php/en/orders/6951-order-on-approval-of-the-price-list-of-paid-services-provided-by-the-scientific-center-of-drug-and-medical-technologies-expertise-n-029-a-22-of-february-14-2022)

Decree of the Government of the Republic of Armenia N 2143-N of December 23, 2021 on making changes and additions in Decree of the Government of the Republic of Armenia...

See hyperlink (File available in armenian) Decree of the Government of the Republic of Armenia N 2143-N of December 23, 2021...

Announcement about medicine registration by EAEU rules

We would like to inform you that in the process of bringing the registration dossier into compliance with the requirements...

Announcement

According to the order of the Ministry of Health of the Republic of Armenia N147-A dated November 11, 2021, Arayik...

Order of Minister of Health of the Republic of Armenia N335-A of February 05, 2021 On defining of new validity data of Good Manufacturing Practice certificates for manufactures in...

When should be submitted application for renewal

Within a period of 5 working days following the entry into force of the order of the authorized body relating...

Information about national procedure registration

Dear Sir/Madam, We would like to inform you that until July 1, 2021 (for all EAEU Member States, except...

Information about ATC code

Dear Colleagues, Please be informed that henceforth you can also search medicinal products by ATC code in Database of Registered Medicines.

Announcement on documents submitted to the Scientific Center in connection with the coronavirus epidemic in the Republic of Armenia (18.03.2020)

Dear Sir/Madam,   Due to the epidemic of coronavirus in the Republic of Armenia, the Scientific Centre of Drug and Medical...

Actemra (tocilizumab)

Announcement about variation assessment payment

Dear Sir/Madam, We would like to remind you that according to the Decree of the Government of the Republic of Armenia...

Announcement about approval of the requirements for the responsible person of wholesale distributor for good distribution practice

Dear Sir/Madam, We would like to inform you that on January 16, 2020, the Ministry of Health adopted Order N01-N  “On...

Announcement about approval of the requirements of labeling and packaging for medicinal products, pharmaceutical substances, herbal raw materials, investigational medicinal products, as well as for the patient leaflet, summary of...

Dear Sir/Madam, We would like to inform you that on January 21, 2020, the Ministry of Health adopted Order N02-N “On...

Pharmacovigilance Guideline

Pharmacovigilance Guideline is in the process of being amended.

Veterinary medicinal products re-registration dossier presentation and format (15.07.2019)

Veterinary medicinal products registration dossier presentation and format (15.07.2019)

Notice to Applicants. Veterinary medicinal products (15.07.2019)

Information about the availability the SmPC and Package Leaflet in Armenian language in case of re-registration of medicines

Dear colleagues, We will be inform you that in case of re-registration of medicines under the national procedure  untill  31.12.2020 the...

Frequently Asked Questions (FAQ) (updated 21.02.2021)

Pro-forma invoice for the registration, re-registration, renewal, variation assessment fees (Updated 03.11.2021)

Decree of the Government of the Republic of Armenia N 166-N of February 28, 2019 «On adopting the fees in the Republic of Armenia for assessments in the field of...

Variation dossier (Updated 16.05.2019)

Updated 16.05.2019

Variation Guideline (10.10.2022)

Re-registration dossier presentation and format (Updated 15.05.2019)

Updated 15.05.2019  Dear colleagues, We will be inform you that in case of re-registration of medicines under the national procedure  untill  31.12.2020...

Requirements for the Power of Attorney (Updated 11.11.2021)

Information about documents accompanied to the registration certificate of the medicine

Dear colleagues We inform you that according to the part 18 of article 16 of the Law "On medicines" of the...

Presentation and format of the registration dossier Common Technical Document (CTD) (Updated 13.06.2019)

Updated 13.06.2019.

Variation application (Updated 11.11.2022)

Registration and Re-registration Application (Updated 11.11.2022)

Information on registration dossier of medicinal product (0101176716/27.04.2016)

Dear Sir/Madam, Considering the fact that according to the new law “On Medicines”, discussing in the National Assembly, the registration dossier...

Information concerning the order for submission of registration dossiers, samples and standards to the Scientific Centre (handling/acceptance acts) (0101236415/29.12.15)

 Updated 30.04.2019