Open letter 30.06.2017

On June 29, 2017, the portal www.newsler.ru published a news story with a rather loud headline: "Roszdravnadzor Bans the Sale of Antibiotics from 'AVVA RUS'." The publication included a letter from Roszdravnadzor (the Federal Service for Surveillance in Healthcare) No. 02i-1280/17 dated June 2, 2017, concerning the suspension of the sale of the drug "Erythromycin," batch number 120616. The actual expert conclusion itself was not published. The authors thus admit that the grounds for the conclusion are unknown to them.

Furthermore, the editorial board of www.newsler.ru did not contact JSC "AVVA RUS" or the territorial office of Roszdravnadzor for the Kirov Region to obtain a statement or comment on this matter. Instead, they published an article with a sensational headline which, in our opinion, discredits the activities of the pharmaceutical company JSC "AVVA RUS".

Colleagues from the editorial board of www.newsler.ru, as well as readers of the portal!

I officially declare that today, the products of JSC "AVVA RUS", including antibiotics, are freely sold in pharmacies across the Russian Federation and in foreign countries. The product line, consisting of more than 45 items, is effective and of high quality, guaranteed and confirmed by the company's quality system, as well as by state and independent expert organizations.

Regarding the Roszdravnadzor letter:

The functions of Roszdravnadzor include monitoring and checking the quality of medicinal products. Our products also undergo such control. The inspection reports are published at the following links:

014-500-17-ot-28.02.2017.pdf

01-1221-17-ot-26.05.2017.pdf

During quality control testing of medicinal products, research methodologies use reference standards of a certain quality. These standards are produced by a number of European and American companies that hold licenses and appropriate certifications.

The reason for suspending the sale of one batch of the drug "Erythromycin" is that the expert organization could not evaluate the test results for the parameter "Related impurities" using the method specified in the regulatory documentation. This was due to the experts lacking the reference standard for Erythromycin A (Eur.Ph. catalog number E1310000), as the European manufacturer "EDQM" discontinued the production of this standard effective January 1, 2017.

It is important to note that the medicinal product "Erythromycin tablets, enteric-coated 250 mg," batch 120616, was released for distribution by JSC "AVVA RUS" on July 8, 2016. At that time, the reference standard Erythromycin A (Eur.Ph. catalog number E1310000) was being produced and was available. JSC "AVVA RUS" used it to test the medicinal product "Erythromycin, tablets, enteric-coated 250 mg," batch 120616, for the parameter "Related impurities."

According to the results of testing conducted in the Quality Control Laboratory of JSC "AVVA RUS," the parameter "Related impurities" in batch 120616 of the medicinal product meets the requirements of the regulatory documentation LSR-009315/08-251108. The Certificate of Analysis with the test results for the medicinal product "Erythromycin tablets, enteric-coated 250 mg," batch 120616, and the Declaration of Conformity are available on the company's website at the following links:

120616-eritromicin-pasport.png

120616-eritromicin-declaracia-o-sootvetstvii.png

Given these circumstances, and considering that JSC "AVVA RUS" conducts control of its products throughout their entire shelf life, we have appealed to Roszdravnadzor to resume the sale of the medicinal product and revoke letter No. 02-28119/17 dated June 2, 2017. We expect a response soon.

Respected editorial board of the portal www.newsler.ru! I am deeply convinced that the task of journalists is to convey truthful and reliable information to their readers. Unfortunately, your biased attitude towards JSC "AVVA RUS" prevents you from publishing information about the company in a neutral manner.

I can explain this negative attitude towards our company by our activity in the field of consumer rights protection and our appeals to the Kirov Region OFAS (Federal Antimonopoly Service) regarding the misleading advertising of a dietary supplement produced by LLC "Vostok." The decisions of the Kirov Region OFAS on case No. 29/04-16р dated 09.02.2017 and case No. 30/04-16р dated 09.02.2017 are available at the links:

reshenie-po-delu-29-04-16.pdf

reshenie-po-delu-30-04-16.pdf

This advertising for the dietary supplement from LLC "Vostok" was placed on your portal, and you informed your readers about the therapeutic properties of this product, despite the fact that according to Federal Law, dietary supplements cannot be attributed with therapeutic properties since their therapeutic effect is unproven.

Furthermore, publications on your portal largely mirror those in the newspaper "Reporter," which suggests an affiliation between www.newsler.ru and the newspaper "Reporter."

We remind you that from December 21, 2015, to May 5, 2016, a series of publications appeared on the portal www.newsler.ru and in the newspaper "Reporter" that discredited the activities of JSC "AVVA RUS." The company was accused of violating environmental legislation. However, the ruling of the Arbitration Court in Case No. А28-6563/2016 on the protection of business reputation set everything straight. The court obligated the editorial board of the newspaper "Reporter" to post on the website www.newsler.ru a notice about the satisfaction of the claim by publishing the operative part of the court's decision in case No. А28-6563/2016: rewenie_po_delu_№_а28-6563.pdf

However, the operative part of the decision has not appeared on the portal www.newsler.ru. Consequently, readers remain unaware of the court's decision. Meanwhile, those inaccurate publications remain on the portal's pages and are accessible to readers. I hope that the bailiffs will soon find an opportunity to explain to you that court decisions must be enforced.

Moreover, based on the court ruling, the Directorate of the Federal Bailiff Service for the Kirov Region initiated two enforcement proceedings:

No. 58679/17/43001-IP dated 03.03.2017: Recovery of a state duty of 21,000 rubles.

No. 58678/17/43001-IP dated 03.03.2017: Recovery of a 50,000 ruble enforcement fee and the obligation to publish a retraction of the court's decision regarding the inaccurate information in the newspaper and on the portal.

Also, to date, the Arbitration Court of the Kirov Region has issued a ruling (not yet in force) on the reimbursement of legal costs in favor of JSC "AVVA RUS" in Case No. А28-6563/2016 in the amount of 191,076 rubles and 00 kopecks.

Currently, the arbitration court is considering a lawsuit from JSC "AVVA RUS" against LLC "Editorial Board of the newspaper Nash Variant" in Case No. А28-3455/2017 – reputational damage in the amount of 10,000,000 rubles.

A representative of the founder of the newspaper "Reporter" stated in court that the editorial board does not have such funds. This is indirectly confirmed by information received from bailiffs that LLC "Editorial Board of the newspaper Nash Variant" has no property or bank accounts. This is a paradoxical situation. Any commercial organization aims to make a profit. How the editorial board of the newspaper "Reporter" conducts commercial activity without bank accounts remains a mystery to me, one that should obviously be solved by the staff of the Federal Tax Service (UFNS) for the city of Kirov.

Dear readers, if you see publications about JSC "AVVA RUS" on the portal www.newsler.ru or in the newspaper "Reporter," I ask you to verify the accuracy of the information with company representatives or through reliable sources that are not guided by personal attitudes towards JSC "AVVA RUS" when publishing news.

Respectfully,

General Director of JSC "AVVA RUS"

Alexey Glebovich Egorov