NORWAY Law and Practice Contributed by: Vebjørn Krag Iversen, Nora Bratheim, Kristin Erstad Remvik and Guro S. K. Nybø, Wikborg Rein Advokatfirma AS
cation procedure, the active ingredient, medical indication, prescription status and product type and dosage. • A list of P&R decisions that includes the above- mentioned information (as per the MA granted listed), as well as information about pricing and reimbursement. • When approved, generic drugs for which generic substitution applies, will also appear on the so- called “substitution list”. This list is updated on the first and the 15th day of each month. In addition, information about granted MAs, P&R deci ‑ sions, and substitution status is made available in NMPA’s public database ( Legemiddelsøk ). The data ‑ base is updated shortly after NMPA has granted the MA. Hence, information may be published in NMPA’s database before the aforementioned lists and data‑ bases are updated. Moreover, the product must be listed in the database of the Association of Pharmacies (Farmalogg). In prac ‑ tice, a product is available on the market when it is included in Farmalogg. This register is also updated on the first and 15th day of each month. Freedom of Information Requests Freedom of information requests to NMPA are avail ‑ able under the Freedom of Information Act. Usually, when requests under the Norwegian Freedom of Infor ‑ mation Act are made to NMPA, a reference will be made to the published lists and databases without giving any additional information. Additional informa ‑ tion about pending applications is generally classed as trade secrets, and therefore excluded from the right to information (see Section 13 of the Norwegian Free ‑ dom of Information Act and Section 30 of the Norwe ‑ gian Medicine Act). NMPA will not notify the generic MA applicant/holder if someone (eg, the MA holder of the reference product) requests information under the Norwegian Freedom of Information Act. 2.5 Reimbursement and Pricing/Linkage Markets Generally, NMPA will neither consider the patent situ ‑ ation on its own, nor act upon notifications from the patent holder covering an innovative product, when it
comes to marketing authorisation, pricing and reim ‑ bursement, and generic substitution. There is one exception. According to NMPA’s guide ‑ lines regarding the substitution list, generic drugs cov ‑ ered by a second indication patent are still added to the substitution list – albeit with the instruction that the drug is not to be substituted if the pharmacy is aware that the drug is prescribed for the patented use. Hence, the holder of a second indication patent will regularly notify NMPA following the grant of an MA to a generic product for which the originator holds a second indication patent. The holder of the MA for the reference product is not notified of any MA, P&R or listing applications made by a generic or biosimilar, nor of the grant of such applications. Information may be obtained through freedom of information requests or, alternatively, by monitoring publicly available lists and databases (see 2.4 Publicly Available Drug and Patent Information ).
3. Biosimilar Market Entry 3.1 Infringing Acts See 2.1 Infringing Acts . 3.2 Data and Regulatory Exclusivity
See 2.2 Regulatory Data and Market Exclusivity . 3.3 Acceptable Pre-Launch Preparations See 2.3 Acceptable Pre-Launch Preparations . 3.4 Publicly Available Drug and Patent Information See 2.4 Publicly Available Drug and Patent Informa- tion . 3.5 Reimbursement and Pricing/Linkage Markets See 2.5 Reimbursement and Pricing/Linkage Mar- kets .
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