Lourantos says: 'For example, there is a medicine called Lamictal for epilepsy The parallel pharmaceutical trade started in Holland in the. The MHRA considers each application for a product name to ensure that the In all cases, it may be possible for a branded drug or a parallel import to be conditions or sensitivities should not deviate from their regular medication for safety. Parallel Distribution of medicines provides significant savings to and undergo regular controls by the competent national and European regulatory authorities.
of Parallel Regular Medication Use
Current practice of parallel importation in Kenya. At the moment, parallel importation takes place in a none structured way and only based on individual orders. According to the PPB, the proposed framework will allow the importation on a wider scale to serve the needs of many potential users. Toroitich explained that allowing parallel importation is not similar to allowing substandard drugs into the country.
Instead, the policy is meant to allow entry of cheaper drug products into the country without compromising on their quality. Parallel importation indeed is not a quality issue but one of commercial in nature, it allows the country to take advantage of price differentials of drugs in different geographic markets to avail the drugs cheaply within the Kenyan market. Parallel importation of pharmaceuticals is one of several flexibilities contained in the World Trade Organization trade agreement on Trade-Related Aspects of Intellectual Property Rights TRIPS with opportunities for application for public health purposes.
It is against this background that the Pharmacy and Poisons Board of Kenya is obligated to implement policies that are supportive of the utilization of these TRIPS flexibilities for the benefit of Kenyans. Through implementation of this policy, PPB anticipates bringing down the prices of branded medicine by at least 60 per cent; this is expected to make the drugs affordable.
Whether this anticipated price reduction is ambitious cannot be judged at this point but what is certain however is that with many players participating openly in this trade, prices will drop owing to fierce competition that will result thereby benefiting the end user.
While many products can be imported through parallel channels, it is anticipated that majority of products to be imported will mainly be those drugs that are used to manage lifestyle diseases such as cancer, diabetes, hypertension and other diseases considered costly to treat.
Explaining the proposed procedures for parallel importation of pharmaceuticals, Dr Toroitich emphasizes that the drugs will be imported by pharmacists licensed to trade as wholesalers by the PPB. These pharmacists will undergo vetting by the board and once credibility and reliability of their sources is ascertained, the board will grant them authorization to import the drugs from the registered sources.
Parallel importers will be expected to adhere to high levels of standards with regards to quality, packaging, as well as appropriate labels meeting requirements expected of pharmaceutical products. Other benefits expected to accrue following the implementation of the parallel importation policy is reduction of temptation for counterfeits due to diminished returns attributed to the reduction in prices. This is because many believe that counterfeits come in to take advantage of high prices charged by manufacturers locally which create opportunities for importation of cheaper replacements which end up being counterfeits in many instances.
The PPB is considering other strategies to put pressure on retail price of drugs downwards; introduction of price control which is intended to achieve uniformity on pricing across the country is one of these options.
This must be timely and a reason to smile for many would be beneficiaries coming at a time when many Kenyans are seeking specialized care abroad; if adopted therefore, this will contribute to taming the surging number of Kenyans seeking specialized treatment in India and other countries.
It is estimated that Kenya loses over Sh10 billion in annual revenues spent in foreign countries especially India for treatment that can be availed locally. Quality Assurance and Post-market surveillance of parallel imported products.
Distribution and supply of pharmaceutical products are governed by international rules; there are obligations that are expected of the manufacturer of the drug as well as the distributor.
This is an inherent mechanism to ensure that the quality of the drug is maintained including during use. You do not need to send a list of suppliers you will get the product from if you electronically submit the statement below. The statement should be signed and emailed as a PDF to plpi mhra. I confirm that insert company name MHRA company number insert company number will only obtain parallel import products from suppliers which hold an appropriate authorisation wholesaler or manufacturer licence.
You should submit a variation application to MHRA if changes are made to the product which you are importing. You can do this using the MHRA portal. When the patient information leaflet for the UK cross-referred product has been updated excluding certain administrative changes , the PLPI patient information leaflet will also have to be varied.
If there are any changes to the arrangements for re-packaging the product you need to submit a variation. TaD is a procedure which allows you to submit a variation for a change to the imported product and then carrying on repackaging and distributing the product while MHRA assesses the variation. The incoming product must be linked with the cross-referred UK product via a mutual recognition or decentralised procedure.
It may not be appropriate to submit variations as a TaD if there are other variations to the same product that are not TaDs. Variations using TaD can only be made for the following changes:.
You cannot use a TaD variation to change the imported marketing authorisation number. The list is updated often. Find the marketing authorisation number of the imported product and then make sure the UK MA number on the list is identical to the cross-referred UK licence on your licence. You can then make the changes to the PIL and labels and continue repackaging and releasing the product.
If you are submitting a variation and have discussed the fee with the MHRA PLPI assessment unit you should include confirmation of this agreement in your application. Any submission that does not meet the submission requirements will be invalidated and rejected. You will be told the reasons for the invalidation by email. Once an invalid application has been rejected, the whole application must be re-submitted. To make a PLPI submission you need to complete the application form, including the appropriate UK cross-reference product which the application is based on.
Make a payment to MHRA. If there is information missing from your submission or changes need to be made we will write to you twice. In some cases, MHRA will make an exception, for example when the leaflet for the product is undergoing user testing. This will be decided on a case-by-case basis and only in exceptional circumstances. Fees for PLPI applications and variations. For portal issues email Portal.
If you have a question about the validation of your submission email IPUEnquiries mhra. For information about the progress of your application email ris. For more general enquiries about PLPIs email info mhra. To help us improve GOV. It will take only 2 minutes to fill in. Skip to main content. Home Health and social care Medicines, medical devices Marketing authorisations, variations and licensing guidance. Published 21 January Last updated 22 February — see all updates.
Medicines and Healthcare products Regulatory Agency. Contents Overview Parallel import licence application categories Labels, patient information leaflets and packaging Company functions involved in parallel importing Make a variation to your parallel import licence Renew your parallel import licence Inspections of parallel import companies Submit your parallel import Documents for submission Fees Contact.
Overview The UK parallel import licensing scheme lets a medicine authorised in another EU Member State be marketed in the UK, as long as the imported product has no therapeutic difference from the same UK product. If you want to parallel import a product you must make sure that: Parallel import licence application categories Parallel import licence PLPI applications fall into 3 categories.
Parallel import simple A simple parallel import licence can be granted when:
Medicines: apply for a parallel import licence
Parallel importation of drugs to lower cost of medication | Blog application and a decision to allow importation would be made by the PPB to bring in just getting whether through the normal channels or parallel import of acceptable quality. This page lists questions about parallel distribution. The information is available as questions and answers, which the European Medicines Agency (EMA). provisions that allow parallel trade; the safety of imported drugs; the distribution of cost . member states have policies promoting the use of parallel imports.