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On the third Saturday of September, all pharmacists of Ukraine celebrate their professional holiday - the Day of the Pharmaceutical Worker of Ukraine. This is not only a holiday for pharmacists, but also for pharmacists, organizations for quality control of products, and all those hundreds of thousands of people, it is associated with the production of medicines and dietary supplements! Your work is not just a precise ratio of ingredients, but a daily hard work for the benefit of all.
After all, who knows better than pharmacists which medicine will help to cope with an illness, knows how to create it and knows how to store it correctly? Today, during the world quarantines, each of us once again realized that it is in the hands of doctors and pharmacists that the main asset of all nations is our health!
Not everyone in this world will be able to learn what you are fluent in: only a few will be able to subjugate the fine chemistry of medicines, and only highly qualified people will be able to find the right guidelines among thousands of drug names, and very few will be able to put themselves in the service of people.
The Biofoodpharm company congratulates its employees and all colleagues of the pharmaceutical industry on their professional holiday!
We wish you on this wonderful holiday, first of all, good health, so that you do not have to use your professionalism for yourself.
Family warmth so that you can happily return from your favorite work. And financial well-being, built solely on the sale of vitamins.
Thank you for all the important discoveries in our field!
Happy Holidays! Be healthy!

According to the already established good, the Biofoodpharm team congratulates the partner and CEO of the company - Nataliia Khomenko on reaching the final in the competition "Lawyer of the Year - 2021", which is annually held by the Ukrainian Advocates' Association.
For the third year in a row, Nataliia is absolutely deservedly among the best lawyers in the country in her nomination!
We are proud to work with you as a team on a strategic plan and opening up new international markets!
We wish you continued success, recognition and global business projects!

The company "Biofoodpharm" congratulates all colleagues and partners on the upcoming Independence Day of our country - the 30th anniversary of the proclamation of independence of Ukraine!
We bravely defended our independence, fought, argued and fought, got, lost, created a business, and now - Ukraine is independent! Long live our prosperous, proud, free and strong-minded country!
Let freedom to think and act be our key advantage, both in our country and in the international arena. Be independent and free in all your manifestations and business projects! Peace, prosperity and prosperity to all of us and our country!
We are proud to be Ukrainians!

Availability of Insulin Products Will Help Increase Access and Potentially Lower the Cost of Insulin for People with Diabetes
Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.
Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means you can expect the same safety and effectiveness from the biosimilar as you would the reference product.
An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called "pharmacy-level substitution" — much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.
All biological products are approved only after they meet the FDA's rigorous approval standards. The approval of Semglee (insulin glargine-yfgn) as biosimilar to, and interchangeable with Lantus (insulin glargine), is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) in terms of safety, purity and potency (safety and effectiveness). It also showed that Semglee (insulin glargine-yfgn) can be expected to produce the same clinical result as Lantus (insulin glargine) in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee (insulin glargine-yfgn) and Lantus (insulin glargine) is not greater than the risk of using Lantus (insulin glargine) without such switching.

On June 23, 2021 in the Committee of the Verkhovna Rada of Ukraine on the health of the nation, medical care and medical insurance, a round table was held to discuss problematic issues of the draft law "On Medicinal Products", registered in the Verkhovna Rada of 21.05.2021, No. 5547.
The event was attended by People's Deputies, Chairman of the Subcommittee on Pharmacy and Pharmaceutical Activities of the Committee S. Kuzminykh, Chairman of the Committee M. Radutsky, Deputy Chairman of the State Service of Ukraine for Medicinal funds and drug control V. Korolenko, adviser to the head of the Office of the President of Ukraine M. Pasechnik, representatives of specialized public organizations, industry experts.
Within the framework of the round table, problematic issues of the draft law were discussed, such as:
1. Introduction of a new institution of "brokering in the field of drug circulation". It is assumed that such persons will carry out actions for the sale or purchase of medicines, with the exception of wholesale, subject to the rules of good distribution practice (GDP) of medicines, which is mandatory for wholesalers. In this regard, it is necessary to finalize the provisions on brokering in the field of circulation of medicines, supplementing them with the grounds on which they will carry out their activities (agreement or brokerage deal), and to prescribe in detail the delineation of powers between the concepts of "broker" and "agent".
2. Introduction of Good Pharmacy Practice (GPP). In this matter, the problem lies in the fact that the bill provides for mandatory compliance by pharmacies with the GPP requirements, but in the countries of the European Union, the GPP is a recommendation document. In addition, now this document has not been developed by the Ministry of Health of Ukraine, which makes it impossible to implement it after the entry into force of the law, especially without fail.
3. The need to finalize the conceptual apparatus, in particular, the provision of definitions "manufacturer of medicinal products" and "obligations of the manufacturer to sell medicinal products."
4. The event separately discussed the issue of manufacturing medicines in a pharmacy and creating conditions for such activities, since some provisions of the law simply will not allow the production of medicines in a pharmacy. Specialized public organizations have provided proposals on some exemptions for such medicines, regarding their labeling, accompanying information materials, and the availability of a certificate.
5. Proposals regarding the specifics of licensing of business entities were submitted. In particular, the issue of the right of the state control body to fully or partially suspend or revoke the enterprise's license was very important.
6. The issue of the term for issuing licenses was also discussed. The draft stipulates that the license will be issued within a period not exceeding 90 calendar days from the date the state control body receives an application for a license. However, for now, the term is not spelled out in the law, but in the current Licensing Conditions, where the issuance period is not later than 10 working days. Previously, the deputies noted that it is planned to keep the term for issuing a license exactly in the law, but to reduce it to 30 calendar days for licensees of retail and wholesale trade in medicines, and for manufacturers - to leave up to 90 calendar days.
7. The issues of requirements for distance selling of medicines were also discussed in detail. In particular, the draft law does not refer to the Standard Form of the Agreement between the Licensee and the Postal Operator, which must be approved by a resolution of the Cabinet of Ministers of Ukraine. The absence of this provision will create corruption risks and chaos in the drug delivery market.
According to the results of the round table, the proposals of the participants were taken into account by the people's deputies, the deputies are ready to take into account many proposals when finalizing the law for the second reading if it is adopted in the first reading.

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