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Sanjeith K ☆ India, 2016-02-26 10:41 (3312 d 08:27 ago) Posting: # 16030 Views: 8,204 |
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Dear All, We are unable to get reference product of Clomipramine capsules from EU market. As per vendors statement Anafranil tablets are available but Anafranil capsules are not available. We tried with different vendors but the reply is same. Is there any specific way to confirm reference product availability in EU? Regards Sanjeith K Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2016-02-26 13:24 (3312 d 05:44 ago) @ Sanjeith K Posting: # 16031 Views: 6,935 |
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Dear Sanjeith, It depends on the country; I checked a few: In Germany and Austria only the 10/25/75 mg MR tablets are marketed. 50 mg capsules are marketed in Ireland and 10/25/50 mg capsules in the UK. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Sanjeith K ☆ India, 2016-02-27 07:56 (3311 d 11:12 ago) @ Helmut Posting: # 16035 Views: 6,616 |
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Dear Sir, Thank you. Regards Sanjeith K |
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Sanjeith K ☆ India, 2016-03-09 13:07 (3300 d 06:00 ago) @ Helmut Posting: # 16078 Views: 6,139 |
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Dear Sir, We approached manufacturer from member states individually and have got responses from few of them, in that they said that the product was pulled out of the market (including UK) completely. Dear All, If the RLD does not exist with EU, what could be the option for us: Can we use RLD from other regulatory (Canada). Please suggest. Regards Sanjeith K |
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ElMaestro ★★★ Denmark, 2016-03-09 14:48 (3300 d 04:20 ago) @ Sanjeith K Posting: # 16079 Views: 6,212 |
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Hi Sanjeith K, in your case I would lean on directive 2001/83 §10.2b if we are talking IR: " ‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product (...) The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form." - which means: try and find a immediate release tablet if you can. If your formulation is the MR version then of course this is meaningless. Forget about using a Canadian ref. in EU. — Pass or fail! ElMaestro |
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shakeel.salam ☆ India, 2016-03-11 11:36 (3298 d 07:32 ago) @ Sanjeith K Posting: # 16095 Views: 6,059 |
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Dear Sanjeith Reference must be made to a product which is or has been authorised in the Union, (i.e. a marketing authorisation has been granted for the reference medicinal product, but it may have ceased to exist) and in accordance with the Union law In case, the reference medicinal product is no more produced and placed on the Union market, demonstration of the bioequivalence with the reference medicinal product through bioavailability studies should however be performed on batches which have been authorised within the Union. As per Helmut 50 mg capsules are marketed in Ireland and 10/25/50 mg capsules in the UK. a reference medicinal product in another Member State should be identified, so-called the European reference medicinal product. the applicant has to identify in the application form the name of the Member State in which the reference medicinal product is or has been authorised. It is also a prerequisite that the period of data exclusivity has expired in the Member Stateof the reference medicinal product And I completely agree as per ElMaestro directive 2001/83 10.2b The various immediate-release oral pharmaceutical forms are considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the detailed 'guideline on the investigation of bioequivalence' hope this clarifies. regards shakeel |
Ing. Helmut Schütz