Елена Самтынова
belchonock / Depositphotos.com
С сегодняшнего дня вступают в силу правила, по которым будут вводится в гражданский оборот лекарства без нанесения средств идентификации, произведенные или ввозимые в РФ в период с 1 июля по 1 октября. Напомним, 27 декабря 2019 года принят Федеральный закон от 27 декабря 2019 г. № 462-ФЗ, которым с 1 июля вводятся правила обязательной маркировки лекарственных препаратов для медицинского применения. Теперь Правительство РФ смягчило сроки введения обязательной маркировки путем предоставления возможности производителям лекарств постепенного перехода к новым правилам до октября текущего года. Особенности такого ввода в гражданский оборот не распространяются на отдельные лекарственные препараты, для которых предусмотрены свои условия внедрения системы мониторинга (например, препараты от гемофилии, муковисцидоза, злокачественных новообразований и других заболеваний). Соответствующее Постановление Правительства РФ от 30 июня 2020 г. № 9551 будет действовать с 1 июля по 1 января 2021 года.
Выпуск таможенными органами лекарств, ввозимых в РФ, и ввод их в гражданский оборот будет осуществляться на основании согласования, выданного Росздравнадзором сроком на 45 календарных дней. Для получения такого согласования держатель (владелец) регистрационного удостоверения лекарственного препарата или уполномоченное им лицо должны представить через личный кабинет в информационной системе Росздравнадзора соответствующее заявление. К заявлению следует приложить:
документы о полномочиях на получение согласования; обоснование невозможности нанесения средств идентификации на упаковку в соответствии с законом; копии договоров, свидетельствующие о намерении производить маркировку лекарств (договоров поставки оборудования для маркировки, программного обеспечения); план мероприятий по внедрению системы мониторинга с указанием даты готовности производителя к маркировке лекарственных средств и передаче данных в систему мониторинга.
Все важные документы и новости о коронавирусе COVID-19 – в ежедневной рассылке Подписаться
В течение срока, не превышающего 9 рабочих дней, Росздравнадзор оформит соответствующее согласование или отказ в согласовании и направит его заявителю в виде электронного документа с усиленной квалифицированной электронной подписью. За выдачу согласований, внесение записей в реестр и предоставление сведений из реестра плата не взимается.
Перед вводом в гражданский оборот лекарственного препарата в информационную систему должны быть внесены сведения о наличии или отсутствии на упаковках серии (партии) средства идентификации.
При выявлении Росздравнадзором сведений об отсутствии на лекарственном препарате информации о маркировке после 1 октября будет принято решение о прекращении оборота такого лекарства. Сведения о выданных согласованиях будут доступны на сайте Росздравнадзора.
Отмечено, что введенные в оборот лекарства в соответствии с указанными особенностями согласования подлежат обращению до окончания срока их годности.
_____________________________
1 С текстом Постановления Правительства РФ от 30 июня 2020 г. № 955 «Об особенностях ввода в гражданский оборот лекарственных препаратов для медицинского применения» можно ознакомиться на официальном интернет-портале правовой информации (номер опубликования: 0001202007010013).
Russian
magnificent put up, very informative. I wonder why the opposite experts of this sector don’t realize this. You should continue your writing. I am confident, you’ve a great readers’ base already!
Hi my friend! I wish to say that this article is awesome, great written and include almost all significant infos. I¦d like to peer extra posts like this .
I think this is among the most important information for me. And i’m glad reading your article. But want to remark on few general things, The web site style is perfect, the articles is really nice : D. Good job, cheers
This piece of writing will help the internet people for creating new webpage or even a
weblog from start to end.
Nice post. I was checking continuously this blog and I’m impressed! Extremely useful info specifically the last part 🙂 I care for such information much. I was looking for this certain information for a long time. Thank you and good luck.
he blog was how do i say it… relevant, finally something that helped me. Thanks
Good ?V I should definitely pronounce, impressed with your site. I had no trouble navigating through all the tabs and related information ended up being truly simple to do to access. I recently found what I hoped for before you know it at all. Reasonably unusual. Is likely to appreciate it for those who add forums or anything, website theme . a tones way for your client to communicate. Excellent task..
This is a topic close to my heart cheers, where are your contact details though?
Oh my goodness! a tremendous article dude. Thank you However I’m experiencing situation with ur rss . Don’t know why Unable to subscribe to it. Is there anybody getting identical rss drawback? Anybody who knows kindly respond. Thnkx
Some times its a pain in the ass to read what website owners wrote but this internet site is very user friendly! .
Lovely blog! I am loving it!! Will come back again. I am taking your feeds also.
I carry on listening to the reports talk about getting free online grant applications so I have been looking around for the finest site to get one. Could you advise me please, where could i get some?
I think this site contains some rattling fantastic information for everyone : D.
Nagano Lean Body Tonic: An IntroductionNagano Lean Body Tonic is a dietary supplement designed to help lose unhealthy weight.
After all, what a great site and informative posts, I will upload inbound link – bookmark this web site? Regards, Reader.
Very interesting topic, appreciate it for posting.
Hello there, simply become aware of your blog through Google, and located that it is really informative. I am gonna watch out for brussels. I’ll appreciate in the event you continue this in future. Numerous other folks shall be benefited from your writing. Cheers!
I have been checking out many of your articles and i can claim nice stuff. I will make sure to bookmark your site.
Right now it seems like BlogEngine is the top blogging platform available right now. (from what I’ve read) Is that what you’re using on your blog?
When I initially commented I clicked the «Notify me when new comments are added» checkbox and now each time a comment is added I get four e-mails with the same comment. Is there any way you can remove me from that service? Appreciate it!
LeanBiome is a probiotic dietary supplement that’s packed with lean bacteria species that help support healthy weight loss.
Sight Care is a visual wellness supplement that is currently available in the market. According to the Sight Care makers, it is efficient and effective in supporting your natural vision
hi!,I like your writing very much! share we communicate more about your post on AOL? I need an expert on this area to solve my problem. Maybe that’s you! Looking forward to see you.
Can I just say what a aid to seek out someone who actually is aware of what theyre talking about on the internet. You definitely know how you can convey an issue to mild and make it important. More folks have to learn this and understand this side of the story. I cant imagine youre not more common because you definitely have the gift.
Hi! Someone in my Facebook group shared this website with us so I came to look it over. I’m definitely enjoying the information. I’m book-marking and will be tweeting this to my followers! Exceptional blog and wonderful design and style.
Neat blog! Is your theme custom made or did you download it from somewhere? A theme like yours with a few simple adjustements would really make my blog stand out. Please let me know where you got your design. Kudos
You have mentioned very interesting points! ps nice internet site.
What Is Sugar Defender Supplement? Sugar Defender is a plant-based supplement and it helps to regulate the blood sugar levels in the body.
Thank you for sharing excellent informations. Your web site is very cool. I’m impressed by the details that you have on this blog. It reveals how nicely you perceive this subject. Bookmarked this website page, will come back for more articles. You, my pal, ROCK! I found simply the info I already searched all over the place and simply could not come across. What an ideal web-site.
Sweet website , super style and design, really clean and apply genial.
I have been exploring for a little bit for any high quality articles or weblog posts in this kind of house . Exploring in Yahoo I at last stumbled upon this web site. Reading this info So i am satisfied to express that I have an incredibly good uncanny feeling I came upon exactly what I needed. I so much definitely will make sure to don’t put out of your mind this website and provides it a look on a continuing basis.
What Is FitSpresso? FitSpresso is a natural weight loss supplement that alters the biological cycle of the body to burn more calories and attain a slim and healthy body
Magnificent site. Lots of helpful information here. I am sending it to several buddies ans also sharing in delicious. And naturally, thanks for your effort!
Enjoyed looking through this, very good stuff, thankyou.
hello!,I like your writing very much! share we communicate more about your article on AOL? I need an expert on this area to solve my problem. May be that’s you! Looking forward to see you.
Hello! I just would like to give a huge thumbs up for the great info you have here on this post. I will be coming back to your blog for more soon.
Its like you read my mind! You seem to know so much about this, like you wrote the book in it or something. I think that you can do with some pics to drive the message home a bit, but other than that, this is magnificent blog. An excellent read. I’ll definitely be back.
Nice post. I study one thing more difficult on different blogs everyday. It would always be stimulating to learn content material from other writers and observe a little bit something from their store. I’d prefer to make use of some with the content on my blog whether or not you don’t mind. Natually I’ll provide you with a link on your internet blog. Thanks for sharing.
Very interesting subject , regards for posting.
Great wordpress blog here.. It’s hard to find quality writing like yours these days. I really appreciate people like you! take care
I’m not that much of a internet reader to be honest but your sites really nice, keep it up! I’ll go ahead and bookmark your site to come back down the road. All the best
Thanks for every other fantastic post. The place else could anyone get that type of information in such an ideal means of writing? I’ve a presentation subsequent week, and I am on the look for such information.
You made some clear points there. I did a search on the issue and found most individuals will agree with your site.
I am continually searching online for tips that can facilitate me. Thanks!
Thanks a lot for sharing this with all folks you really understand what you are speaking approximately! Bookmarked. Please additionally visit my web site =). We will have a hyperlink trade agreement among us!
Heya! I’m at work surfing around your blog from my new iphone 3gs! Just wanted to say I love reading through your blog and look forward to all your posts! Keep up the outstanding work!
Hiya, I am really glad I’ve found this information. Today bloggers publish only about gossips and internet and this is really frustrating. A good site with exciting content, this is what I need. Thank you for keeping this website, I’ll be visiting it. Do you do newsletters? Can’t find it.
This is really fascinating, You’re an excessively skilled blogger. I have joined your feed and look forward to in search of extra of your excellent post. Additionally, I have shared your web site in my social networks!
Thanx for the effort, keep up the good work Great work, I am going to start a small Blog Engine course work using your site I hope you enjoy blogging with the popular BlogEngine.net.Thethoughts you express are really awesome. Hope you will right some more posts.
Wow, marvelous blog layout! How long have you been blogging for? you make blogging look easy. The overall look of your website is wonderful, let alone the content!
Thank you, I have just been searching for information approximately this topic for a long time and yours is the greatest I have discovered so far. However, what concerning the conclusion? Are you sure in regards to the supply?
I’ve been browsing online more than 3 hours nowadays, yet I by no means found any attention-grabbing article like yours. It is beautiful price sufficient for me. Personally, if all website owners and bloggers made just right content material as you probably did, the internet will likely be a lot more helpful than ever before.
I conceive this internet site contains some real great information for everyone :D. «The test of every religious, political, or educational system is the man that it forms.» by Henri Frdric Amiel.
ProNerve 6 nerve relief formula stands out due to its advanced formula combining natural ingredients that have been specifically put together for the exceptional health advantages it offers.
Excellent web site. Plenty of useful info here. I?¦m sending it to some buddies ans also sharing in delicious. And certainly, thanks for your sweat!
Very efficiently written post. It will be beneficial to anybody who utilizes it, including me. Keep doing what you are doing — looking forward to more posts.
I do not even know how I ended up here, but I thought this post was good. I do not know who you are but certainly you are going to a famous blogger if you aren’t already 😉 Cheers!
I have recently started a website, the info you provide on this web site has helped me greatly. Thank you for all of your time & work. «If you see a snake, just kill it. Don’t appoint a committee on snakes.» by H. Ross Perot.
Thank you, I have just been looking for info approximately this subject for a while and yours is the greatest I have found out so far. However, what about the bottom line? Are you sure in regards to the source?
Those are yours alright! . We at least need to get these people stealing images to start blogging! They probably just did a image search and grabbed them. They look good though!