Dp hydro hydrocodone syrup

Dp hydro hydrocodone syrup

Lower risk medicines containing pre-approved, low-risk ingredients and medicines with limited therapeutic claims, such as over-the-counter products, can be simply listed on the ARTG.319 In seeking registration of a pharmaceutical product on the ARTG, a pharmaceutical company (the sponsor) submits a dossier of information to the TGA demonstrating the medicine's safety, efficacy and quality.

Where the medicine relates to a chemical entity that has not previously been registered on the ARTG, the data contained in the dossier are often the result of substantial investment by the sponsor in clinical trials and testing. These data are not published or released; they are dp hydro hydrocodone syrup used internally by TGA and retain their status as confidential information unless and until they are voluntarily made public by the sponsor. As part of an abbreviated marketing dp hydro hydrocodone syrup approval process, these data can be relied upon at a later date by the same or another company to obtain registration for medicines which are 'bioequivalent' to the original.

This avoids unnecessary duplication of clinical trials.

However, a condition is placed on the use of the data to prevent imitators freeriding on sponsors' expenses in conducting clinical trials and tests.

This condition is known as data protection, or data exclusivity. Data protection prevents the regulator, for a limited time, from relying on the data without the permission of the sponsor for the purpose of approving generic copies of the registered product. Australia provides five years of protection for undisclosed data submitted to dp hydro hydrocodone syrup the TGA for the registration of products containing a new active pharmaceutical ingredient (API). Although data protection prevents unauthorised use of the sponsor's data by the TGA, another pharmaceutical company is not prevented from conducting its own clinical trials and presenting its results in a full application for regulatory approval. Alternatively, a generic applicant is not precluded from making a literature based submission.

9.1.3.Australian law on data protection Data protection is governed by s.25A of the Therapeutic Goods Act 1989 (Cth).

It was introduced through amending legislation in 1998.320 The period of five years data protection applies from the date the product is registered on the ARTG. Data protection applies to therapeutic goods consisting, or containing, an active component not previously registered on the ARTG. An active component is defined in s.25A(3) as a substance, or one of the substances which, together, are primarily responsible for the biological or other effect identifying the goods as therapeutic goods.

Data protection applies to the first application for the active component.

Therefore, new dosage forms, routes of administration, new indications, or combinations with other substances are excluded. Therapeutic devices are also excluded from data protection. Data protection only applies to information provided for registrations on the ARTG.321 Products which are listed on the ARTG such as most complementary medicines, do not receive data protection for the information provided to the TGA.

Due to their nature, many listed complementary dp hydro hydrocodone syrup medicines may also hydrocodone availability not be eligible for patent protection. 9.1.4.Comparison internationally Australia is among a large number of nations providing data protection.

Australia, New Zealand, Singapore and Korea have a similar approach to data protection, with a 5 year term available for new APIs. A variety of approaches are taken by other countries, as described in Table 9.1 below. Table 9.1 - Data Protection Periods 329 Country Length Conditions United States 5 years New API 4 years Where a paragraph IV certification is made.322 4 years Biologics (a further eight year period of marketing exclusivity applies).323 7 years 'Orphan drugs' (those intended to treat diseases and conditions that affect 200,000 or fewer people in the United States) 12 years New biological molecules + 6 months Paediatric clinical trial completed European Union Up to 11 years New API (8 years data protection plus 2 years marketing exclusivity plus 1 year further marketing exclusivity where a new indication is approved within 8 years: 8+2+1). 10 years 'Orphan drugs' (regulator cannot accept applications during this period) Japan324 8 years New API 10 years 'Orphan drugs' Canada 8 years New API + 6 months Paediatric indication approved Israel 6 years New API approved in Israel, or 6 years and 6 months from the date of approval in a 'recognised country', whichever is earlier. China 6 years New API Note: Many other countries also provide data protection.



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