Sentences with phrase «market authorization»
"market authorization" refers to the official permission or approval given by regulatory authorities to sell or distribute a product in a particular market. It ensures that the product meets the necessary safety, quality, and effectiveness requirements before it can be sold to consumers. Full definition
When — The trigger event is a drug's first «market authorization for sale» — definition to follow in the regulations.
slaw.ca
It is not limited to patents owned by the brand who receives market authorization.
Regulatory work encompasses the likes of market authorization of products, government affairs, competition matters and compliance work.
Notably, in May 2016 the European Commission granted marketing authorization for Strimvelis for the treatment of ADA - SCID, a severe form of immunodeficiency.
In this particular case, it was of course not very hard to obtain the consent of the first marketing authorization holder, as Novartis was the sponsor for both drugs.
Elanco Animal Health, which manufactures and markets Galliprant (grapiprant tablets) under a license from Aratana, reported Jan. 11 that the European Commission granted marketing authorization in the European Union.
The protection given under a CSP is intended to «partly compensate for time spent in research and obtaining marketing authorization.»
The Madison, New Jersey, company reported March 21 that the European Medicines Agency's Committee for Medicinal Products for Veterinary Use «adopted a positive opinion recommending marketing authorization» for Bravecto Plus (fluralaner plus moxidectin).
In the group of patents issued before market authorization, all patents are accorded equal priority and in such instances challenges must be made to the Federal Court for determination as to whether a disputed SPC has complied with threshold requirements (ie.
In the group of patents issued after market authorization, the earliest issued patent is accorded priority.
One update was that the European Medicines Agency (EMA) had accepted the conditional marketing authorization (CMA) application for avacopan for review.
Finch will be licensing OpenBiome's biomanufacturing quality systems and incorporating manufacturing upgrades as well as its own drug delivery technology to prepare the product for clinical trials and eventual marketing authorization.
However, 23andMe may provide health - related results in the future, dependent upon FDA marketing authorization.
The Company expects the number of patients will be increasing in the course of 5 years up to 20 000 — to start with, in 2012 HSCI plans to initiate Neovasculgen market authorization in Ukraine.
To develop an interface with bio-industry and devise a product - specific regulatory strategy that is compatible with a future marketing authorization;
Many of these products are reaching late - phase trials with the potential to receive final approval and marketing authorization from regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
it pertains to a medicinal ingredient, an SPC has not previously been granted in respect of the same first market authorization etc.).
Promote and support pre-clinical and clinical research on the use of cannabis and cannabinoids for medical purposes, with the aim of facilitating submissions of cannabis - based products for market authorization as drugs
LEAWOOD, Kan. (U.S.)(For EU audience), January 11, 2018 — Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY) and Aratana Therapeutics, Inc. (NASDAQ: PETX), today announced the European Commission adopted the decision to grant marketing authorization of GALLIPRANT ® (grapiprant tablets) in the European Union.
The European Commission recently granted marketing authorization for Cervarix as a two - dose schedule for girls aged 9 - 14 years, and outside of the EU, the Cervarix two - dose schedule is approved in more than ten countries, including Panama, Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria, Ghana, Pakistan, and Bangladesh.
• Documented success in negotiating with regulatory authorities to obtain marketing authorizations.
Additional requirements mandate filing for market authorization in Canada within a certain prescribed time following foreign regulatory market applications.
The company announced in September that Health Canada granted market authorization to formally transfer the Drug Identification Number (DIN) ownership of Belbuca (buprenorphine) buccal film in Canada to BDSI's commercial partner, Purdue Pharma in Canada.
«Consequently we are currently in a catch - 22 situation, since only the «owners» of a market authorization can apply for a new indication!»
· free protocol assistance from the European Medicines Agency on conducting clinical trials and advising the applicant through the Marketing Authorization Application (MAA) process
At the same time, we will also issue a compliance policy that, with the exception of outliers potentially harming public health in a significant way right now, will give current product developers a very reasonable period of time to interact with the FDA in order to determine if they need to submit an application for marketing authorization and to come into the agency and work on a path toward approval.
Sander van Deventer has had a critical role in the development of the first commercial monoclonal antibody (Remicade) and the first gene therapy to be granted market authorization in the Western world (Glybera).
Sander van Deventer has had a critical role in the development of the first commercial monoclonal antibody and the first gene therapy to be granted market authorization in the Western world.
AMT in 2010 submitted a Marketing Authorization Application (MAA) for their lead product GLYBERA ®, a gene therapy for the treatment of lipoprotein lipase deficiency (LPLD), to the European Medicines Agency (EMA, formerly known as EMEA).
April 19 (Reuters)- AB SCIENCE SA:
* REG - AB SCIENCE ANNOUNCES THAT THE CHMP HAS ADOPTED A NEGATIVE OPINION FOR THE MARKETING AUTHORIZATION OF MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS
* AB SCIENCE WILL PROVIDE ADDITIONAL DATA THROUGH A REEXAMINATION PROCEDURE
* RE-EXAMINATION WILL LEAD CHMP TO...
LEAWOOD, Kan. (U.S.)(For EU audience), November 10, 2017 — Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY) and Aratana Therapeutics, Inc. (NASDAQ: PETX), today announced the European Medicine Agency's (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion to recommend the marketing authorization of GALLIPRANT ® (grapiprant tablets) in the European Union.
Chile is the first country to grant marketing authorization to the treatment.
The products discussed herein may not have marketing authorization or may have different product labeling in different countries.
[5] Interestingly the current draft Bill only links the patent and the drug, and does not recite any necessary link between the SPC applicant and the entity receiving the «market authorization».
The priority of SPC applications depends on whether patents are issued before or after «market authorization».
In other words, the SPC provides a benefit where there has been at least a 5 year delay from filing a patent to market authorization.
The period starts with either the market authorization date (where a patent was previously issued) or the patent issue date (if market approval was previously obtained).
A patent issued before market authorization has priority over patents issued after market authorization (as would be expected, given that earlier issued patents have had more of their patent monopoly wasted during government approval).
Citing a hypothetical scenario, Teva claimed that if marketing authorization for nilotinib was granted in November 2011, then the interpretation adopted by EMA would have prevented imatinib generic filings until November 2021, i.e. for twenty years from its first marketing authorization date.
In November 2007 another Novartis drug, Tasigna ® (nilotinib), was submitted for marketing authorization for CML, but since it was found to be structurally similar to imatinib by the EMA, Novartis was obligated to obtain consent from the first marketing authorization holder under Article 8 (3)(a) of the Orphan Drugs Regulation due to the existing orphan exclusivity of imatinib.
It further explained that Article 8 (3)(a) provides that marketing authorization may be granted with the consent of the marketing authorization holder of the first orphan product.
In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the so - called 648 List after the product has obtained a marketing authorization, at least until the company starts to commercialize it in Italy.
the Secretary of State for Health's decision not to grant a marketing authorization for a medicinal product.