Anvisa publica nota técnica sobre lubrificantes e lágrimas artificiais

Publicado 26/03/2015 

A Anvisa publicou a Nota Técnica nº 55/2015/GGMED/ANVISA, que trata do reenquadramento de lágrimas artificiais e lubrificantes oculares como medicamentos específicos e traz orientações importantes ao setor regulado, elucidando dúvidas acerca da nova RDC 05/2015 e documentos necessários ao registro destes produtos.

Atualmente, a legislação define como lágrimas artificias e lubrificantes oftálmicos aqueles produtos que contêm emolientes (geralmente polímeros solúveis em água, como derivados de cellulose, dextrano 70, gelatina, poliois, álcool polivinílico ou povidona) e são aplicados topicamente no olho para proteger e lubrificar a superfície mucosa, aliviando a irritação, ardor e secura dos olhos.

Os produtos oftálmicos contendo associações entre emolientes e substâncias farmacologicamente ativas ou substâncias farmacologicamente ativas isoladas permanecem enquadrados em suas categorias atuais, não sendo tratados pela nota técnica.

Os medicamentos que tiveram o registro solicitado antes da publicação da RDC 05/2015, com enquadramento distinto da classe de medicamentos específicos, e que ainda não foram avaliados pela Anvisa, serão reenquadrados e avaliados como medicamentos específicos. A documentação faltante será solicitada por meio de notificação de exigência.

Já os medicamentos registrados como novos, similares ou genéricos, passam a ser enquadrados como medicamentos específicos a partir da publicação da RDC 05/2015. Desse modo, a próxima petição a ser realizada junto a Anvisa – alteração pós-registro, renovação, HMP – deverá ser realizada com enquadramento como “ESPECÍFICO”.

No caso dos medicamentos que tiveram o registro solicitado antes da publicação da RDC 05/2015 com outro enquadramento que não na classe de medicamentos específicos, e que estão em análise, a análise da petição será transferida para a Coordenação de Medicamentos Específicos, Notificados e Gases Medicinais (COGEN) e, se necessário, será emitida uma nova exigência para que a empresa apresente os documentos faltantes. O assunto da petição será atualizado e a decisão da solicitação de registro já será publicada como referente ao registro de medicamento específico.

Fonte: Anvisa

Foto: Feepik


37 Comentários

  • Duree Efficacite Viagra Kamagra Gold Side Effects Ovral cialis 5mg Precio De Keflex En Mexico Will Propecia Work For Me Testosterone Levels

  • I simply want to tell you that I am just newbie to blogging and absolutely savored this web site. Most likely I’m want to bookmark your blog post . You really come with terrific posts. Appreciate it for sharing your website.

  • This is really interesting, You’re a remarkably professional article writer. I have enrolled with your feed and furthermore , count on enjoying the really great write-ups. And additionally, I’ve got shared your webpage throughout our myspace.

  • whoah this blog is great i love reading your articles. Keep up the great work! You know, many persons are looking round for this info, you could help them greatly.

  • MetroClick specializes in building completely interactive products like Photo Booth for rental or sale, Touch Screen Kiosks, Large Touch Screen Displays , Monitors, Digital Signages and experiences. With our own hardware production facility and in-house software development teams, we are able to achieve the highest level of customization and versatility for Photo Booths, Touch Screen Kiosks, Touch Screen Monitors and Digital Signage. Visit MetroClick at or , 121 Varick St, New York, NY 10013, +1 646-843-0888

  • Faytech North America is a touch screen Manufacturer of both monitors and pcs. They specialize in the design, development, manufacturing and marketing of Capacitive touch screen, Resistive touch screen, Industrial touch screen, IP65 touch screen, touchscreen monitors and integrated touchscreen PCs. Contact them at, 121 Varick Street, New York, NY 10013, +1 646 205 3214

  • I simply couldn’t leave your website before suggesting that I really enjoyed the standard information an individual supply on your visitors? Is going to be again continuously to check up on new posts

  • Attractive section of content. I just stumbled upon your site and in accession capital to assert that I acquire actually enjoyed account your blog posts. Any way I will be subscribing to your feeds and even I achievement you access consistently quickly.

  • Good ¡V I should certainly pronounce, impressed with your website. I had no trouble navigating through all the tabs and related info ended up being truly simple to do to access. I recently found what I hoped for before you know it in the least. Quite unusual. Is likely to appreciate it for those who add forums or anything, site theme . a tones way for your customer to communicate. Excellent task..

  • What would you recommend your customers do in the first few weeks of using your product?

  • As I web-site possessor I believe the content matter here is rattling magnificent , appreciate it for your hard work. You should keep it up forever! Good Luck.

  • Hello very cool web site!! Man .. Excellent .. Superb .. I’ll bookmark your blog and take the feeds also¡KI am glad to find numerous useful info right here within the post, we’d like develop more strategies on this regard, thank you for sharing. . . . . .

  • Great write-up, I¡¦m normal visitor of one¡¦s blog, maintain up the excellent operate, and It’s going to be a regular visitor for a long time.

  • very good article, i definitely love this excellent website, keep on it

  • I am no longer sure where you are getting your information, however great topic. I must spend some time studying much more or figuring out more. Thanks for wonderful information I was in search of this info for my mission.

  • Thanks a lot for sharing this with all of us you actually recognize what you are speaking about! Bookmarked. Kindly additionally seek advice from my web site =). We may have a hyperlink alternate contract between us!

  • I truly appreciate this post. I have been looking all over for this! Thank goodness I found it on Bing. You have made my day! Thank you again

  • Saved as a favorite, I really like your blog!

  • I¡¦ll immediately grasp your rss as I can not in finding your e-mail subscription link or newsletter service. Do you’ve any? Kindly permit me recognize in order that I could subscribe. Thanks.

  • I’ve been absent for a while, but now I remember why I used to love this web site. Thank you, I will try and check back more often. How frequently you update your site?

  • Good write-up, I¡¦m regular visitor of one¡¦s website, maintain up the nice operate, and It is going to be a regular visitor for a long time.

  • bookmarked!!, I really like your blog!

  • There is obviously a lot to know about this. I think you made various good points in features also.

  • Hello outstanding website! Does running a blog
    similar to this require a massive amount work? I
    have virtually no expertise in programming however I had been hoping
    to start my own blog soon. Anyways, if you have any
    ideas or tips for new blog owners please share. I know this
    is off subject nevertheless I simply needed
    to ask. Thanks!

  • I have been absent for some time, but now I remember why I used to love this blog. Thanks , I¡¦ll try and check back more frequently. How frequently you update your website?

  • My wife and i got really ecstatic Ervin managed to finish off his preliminary research via the ideas he came across in your web site. It is now and again perplexing just to possibly be giving freely instructions men and women could have been making money from. Therefore we fully grasp we have got you to appreciate because of that. These illustrations you have made, the simple website navigation, the friendships you can help engender – it’s everything overwhelming, and it is facilitating our son in addition to our family know that this subject matter is excellent, which is certainly unbelievably essential. Many thanks for all!

  • Thank you for the good writeup. It in fact was a amusement account it. Look advanced to more added agreeable from you! However, how can we communicate?

  • As I web site possessor I believe the content material here is rattling excellent , appreciate it for your hard work. You should keep it up forever! Best of luck.

  • Hi my family member! I want to say that this post is amazing, great written and include approximately all vital infos. I¡¦d like to look more posts like this .

  • Usually I don’t learn article on blogs, however I would like to say that this write-up very forced me to try and do it! Your writing style has been amazed me. Thanks, quite great article.

  • Wow! This can be one particular of the most useful blogs We’ve ever arrive across on this subject. Basically Excellent. I’m also an expert in this topic therefore I can understand your effort.

  • Thank you for some other informative website. The place else could I am getting that type of information written in such a perfect way? I have a mission that I am simply now running on, and I’ve been at the look out for such info.

  • I haven¡¦t checked in here for a while since I thought it was getting boring, but the last few posts are great quality so I guess I will add you back to my daily bloglist. You deserve it my friend 🙂

  • Heya i’m for the first time here. I found this board and I find It truly useful & it helped me out much. I hope to give something back and help others like you aided me.

  • Thanks so much for providing individuals with an extremely special chance to read articles and blog posts from this web site. It is often so amazing and as well , full of a great time for me personally and my office co-workers to visit your web site at the very least thrice in 7 days to learn the fresh items you have. Of course, we are usually impressed with the astonishing hints you give. Selected 4 ideas in this posting are surely the most suitable we have had.

  • fantastic publish, very informative. I wonder why the other specialists of this sector don’t understand this. You must continue your writing. I am sure, you’ve a great readers’ base already!

  • I simply desired to appreciate you once more. I do not know the things I would have accomplished in the absence of those smart ideas discussed by you relating to such industry. It was actually the daunting matter in my position, nevertheless noticing your professional strategy you resolved it forced me to cry with fulfillment. Extremely grateful for your information and in addition sincerely hope you really know what a great job you’re providing instructing men and women through your web site. I’m certain you’ve never encountered all of us.

Deixe uma resposta