LANES | Industries
Amendments to the law
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The pharmaceutical industry operates within one of the most highly regulated business environments. Successfully bringing products to market and maintaining commercial operations requires not only regulatory compliance but also a well-designed legal strategy.
Our practical industry experience enables clients to navigate complex regulatory requirements, engage confidently with healthcare regulators, mitigate legal risks, and build sustainable commercial operations in Kazakhstan.
In practice
We choose the registration route (national or EAEU), draw up a plan for documents and timing, and prepare agreements with the marketing authorisation holder and the distributor.
We prepare and file the application, respond to notices and comments, support the inclusion of the product in the order and advise on pricing rules.
We set rules for interacting with medical and pharmaceutical professionals and assess promotion projects and campaigns in pharmacy chains.
We check advertising and materials for professionals against the law, adapt foreign materials and prepare them for approval by the regulator.
We analyse the grounds and the requirements, prepare a position and documents, support you during the inspection and challenge an order or a fine if it is unfounded.
We check the termination terms of the current agreement, the risk of claims and the handover of stock, and prepare a new agreement covering quality liability and delivery terms.
Our solutions
We advise pharmaceutical manufacturers, marketing authorization holders, importers, distributors and medical device companies on:
Practice areas
We support manufacturers, importers, distributors, pharmacy chains and healthcare providers — from registering products and prices to disputes with the regulator.
State registration of medicines and medical devices under the national procedure and under EAEU rules: the dossier, work with the expert organisation, responses to comments, variations and re-registration.
Licensing of pharmaceutical and medical activities and compliance: preparation for regulatory inspections, internal procedures and the documents the regulator requests.
Supply structure and allocation of quality liability:
Requirements for labelling and traceability of medicines: how to set up processes at the manufacturer, importer and distributor, and how to deal with a breach before it becomes a fine.
Registration of maximum prices for medicines and medical devices, procurement under the guaranteed free medical care and compulsory health insurance, agreements with the single distributor:
So that promotion of medicines and medical devices does not become grounds for an inspection:
We handle the legal matters every company faces, whatever its industry:
How it works
A call or a meeting: you describe the situation, we ask follow-up questions, request documents and determine which rules apply and which authorities and organisations we will need to deal with.
We propose the course of action, timing by stage and the fee — fixed for the result or hourly. You know the budget before the work starts.
We prepare documents, correspond with government authorities or the organisations involved and report on every significant step. Each matter has one lawyer in charge.
We hand over the final documents and recommendations. We agree on a retainer — for new deals, changes and inspections.
Budget
Timing depends on the procedure. We provide advice and review documents within a few business days; registration of products and prices and licensing take as long as the regulator's procedure allows — we give you a realistic timeline before we start.
The fee is set for the task: a fixed price for the result, hourly billing or a monthly retainer for ongoing support. You can get a preliminary estimate in the fee calculator — in a couple of minutes and with no obligation.
Questions
Yes, in addition to the national procedure there are EAEU registration rules. The choice depends on the target markets and on the stage of the dossier; we compare the options by timing and cost.
Yes, pharmaceutical activity, including wholesale, is licensed. In addition, the warehouse and processes must meet the applicable requirements — we help you build compliance.
Advertising of prescription medicines to the general public is not allowed; information about them is intended for medical and pharmaceutical professionals. We review materials before they are published.
Act promptly: check the grounds and the response deadline, gather the documents and appoint a person in charge. We prepare the response, work with inspectors and help settle the notice.