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Observer
3 days ago
- Health
- Observer
Health ministry unveils ad norms for medicines
To enhance public health safeguards and ensure ethical, accurate representation of pharmaceutical products, the Ministry of Health on Sunday issued Ministerial Resolution No 135/2025, which specifies the conditions and procedures for advertising or promoting medicines. The resolution bans advertising or promoting medicines by any entity other than pharmaceutical companies, local agents, or pharmaceutical consulting offices, with the exception of scientific offices, unless they have obtained prior authorisation from the Drug Safety Centre (DSC). To obtain a licence, the medicine must be officially registered and that the advertisement content be consistent with the internal leaflet and the Summary of Drug Properties (SmPC) specifying the target groups for the advertisement. According to the decision, the advertisement must also adhere to public order and public morals and be free of any content that could harm public health or contain misleading information, exaggerations or insults to other medicines in accordance with the DSC's approved advertising guide. The DSC allows a period not exceeding 60 days to review and decide on the licence application. Failure to respond within this period shall be considered a rejection of the application. In case of missing documents or information, the applicant will be notified and given 30 days to complete the missing information, otherwise, the application will be cancelled. The applicant may submit a new application 30 days after the date of the rejection decision. The licence term is set at 3 months, renewable with the same conditions. The renewal application must be submitted at least 20 days before the licence expires. The decision allows for the submission of a grievance to the Minister of Health within 60 days of the rejection decision. A decision must be made within 30 days. Failure to decide within this period constitutes a rejection of the grievance. The DSC also has the right to suspend the licence if health risks or the drug's ineffectiveness are identified.
Observer
3 days ago
- Health
- Observer
MoH bans unauthorized medicine commercials
Muscat: The Ministry of Health on Sunday issued Ministerial Resolution No 135/2025, which specifies the conditions and procedures for advertising or promoting medicines. The resolution bans advertising or promoting medicines by any entity other than pharmaceutical companies, local agents, or pharmaceutical consulting offices, with the exception of scientific offices, unless they have obtained prior authorization from the Drug Safety Centre (DSC). In order to obtain a license, the resolution requires that the medicine be officially registered and that the advertisement content be consistent with the internal leaflet and the Summary of Drug Properties (SmPC) specifying the target groups for the advertisement. According to the decision, the advertisement must also adhere to public order and public morals and be free of any content that could harm public health or contain misleading information, exaggerations or insults to other medicines in accordance with the DSC's approved advertising guide. The DSC allows a period not exceeding 60 days to review and decide on the license application. Failure to respond within this period shall be considered a rejection of the application. In case of missing documents or information, the applicant will be notified and given 30 days to complete the missing information, otherwise the application will be cancelled. The applicant may submit a new application 30 days after the date of the rejection decision. The license term is set at 3 months, renewable with the same conditions. The renewal application must be submitted at least 20 days before the license expires. The decision allows for the submission of a grievance to the Minister of Health within 60 days of the rejection decision. A decision must be made within 30 days. Failure to decide within this period constitutes a rejection of the grievance. The DSC also has the right to suspend the license if health risks or the drug's ineffectiveness are identified.
Business Upturn
28-04-2025
- Business
- Business Upturn
Biocon shares jump over 2% after EU panel's positive nod for denosumab biosimilars
Shares of Biocon Ltd rose 2.07% to ₹318.30 in early trade on April 28, 2025, after its subsidiary received a major boost from European regulators. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending the approval of Biocon Biologics' biosimilar denosumab products — Vevzuo and Denosumab BBL — for treating bone health conditions. The positive recommendation is based on extensive clinical data demonstrating comparability with the original reference product in pharmacokinetics, efficacy, safety, and immunogenicity profiles. The applications were submitted by Biosimilar Collaborations Ireland, an indirect wholly owned subsidiary of Biocon Biologics. Advertisement Following this, the European Commission will review the CHMP's recommendations and, after its decision, detailed product information will be published in the Summary of Product Characteristics (SmPC) and the European Public Assessment Reports (EPARs). Other Key Updates: On April 23 , Biocon's board approved fundraising of up to ₹4,500 crore through qualified institutional placements (QIPs), preferential allotments, or private placements. Earlier this month, Biocon Biologics secured USFDA approval for Jobevne (bevacizumab-nwgd), a biosimilar for intravenous use, further strengthening its biosimilars portfolio. Stock Update: At 9:43 AM IST, Biocon shares were trading at ₹318.30, up ₹6.45 or 2.07%, compared to the previous close of ₹311.85. The company's market capitalization now stands at approximately ₹379 billion.
