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Permit from the president of URPL, not the Minister of Health
A change in the body responsible for issuing marketing authorisation for drugs should cut the time required to obtain approval in Poland.
Permit from the president of URPL, not the Minister of Health
How long before generic drugs can be marketed?
Generics are substitutes for an original drug. May they be marketed as soon as the 10-year regulatory protection period for the original (innovative) drug ends?
How long before generic drugs can be marketed?
No EU patent court after all?
Trybunał Sprawiedliwości UE sceptycznie wypowiedział się o zunifikowanym sądownictwie patentowym, które było nadzieją sektora farmaceutycznego na fachowe orzecznictwo. Wciąż mogą jednak powstać polskie wyspecjalizowane sądy patentowe.
No EU patent court after all?
When individual packages or products must be marked with a price
Is a seller free to decide whether or not to mark each package or item with a price, or is this a legal requirement? When is it alright to use a barcode instead of a price?
When individual packages or products must be marked with a price
Confusion in personal data protection obligations in clinical trials
Even though a specific code of conduct and a structured process apply to clinical trials, there are lacking dedicated, specific regulations on protecting the personal data obtained in such trials.
Confusion in personal data protection obligations in clinical trials
When trade inspectors may seize goods
Are trade inspectors entitled to seize a batch of products during an inspection, for as long as it takes to determine whether the products meet applicable quality standards?
When trade inspectors may seize goods
When retailers bear the cost of lab testing of products
A seller may be required to cover the cost of laboratory tests ordered by a trade inspector during the inspection of a business if the tests show that the product does not meet quality or safety standards.
When retailers bear the cost of lab testing of products
Comparative study of food supplement regulations
The Life Sciences Practice Group of the Lex Mundi network, led by Dr Ewa Butkiewicz, a partner at Wardyński & Partners, has published a survey of legal regulations concerning food supplements.
Comparative study of food supplement regulations
Special foods covered by national health service: an opportunity for the foods industry?
A proposed new Act on Reimbursement for Medicinal Products, Foods and Medical Products calls for the Polish national health service to reimburse the costs of “special-purpose foods” when they offer documented health benefits.
Special foods covered by national health service: an opportunity for the foods industry?
Konrad Drozdowski: We strive to raise advertising standards in Poland
Interview with Konrad Drozdowski, executive director of the Polish Advertising Council
Konrad Drozdowski: We strive to raise advertising standards in Poland
Changes in VAT treatment of healthcare services from 1 January 2011
Under amended regulations, starting 1 January 2011 the VAT exemption for healthcare services would be limited to services that meet a new statutory definition of “medical services.”
Changes in VAT treatment of healthcare services from 1 January 2011
Joanna Krakowiak: Clinical trials-costs will rise, quality too
An interview with Joanna Krakowiak from the Life Science and Regulatory Law practice group at Wardyński & Partners
Joanna Krakowiak: Clinical trials-costs will rise, quality too