Deadlines & milestones.

DHPC – Konakion MM paediatric / Konakion MM (phytomenadione)

09.07.2026

Out-of-Stock – Opdualag 240mg/80mg, concentrate for preparation of infusion solution

Opdualag 240mg/80mg concentrate for infusion is out of stock as of 09.07.2026.

Conclusions from the Pharmacovigilance Risk Assessment Committee (PRAC), 6–9 July 2026

Summary of conclusions from the PRAC meeting held 6–9 July 2026; full report available on the European Medicines Agency website.

MRI: Report on emergency surcharges billed by hospitals for non-urgent examinations

09-07-2026 - IRM : Un rapport fait le point sur les suppléments d’urgence facturés par les hôpitaux lors d’examens non urgents

DHPC – Ontozry (Cenobamat)

09.07.2026

MHSYFA Q2 2026: Proposed Prices for Consultation

Greek EOF pricing department proposes medicinal product prices for Q2 2026, open for public consultation.

Paediatric Committee (PDCO): 8-11 September 2026

08 Sep 2026 Paediatric Committee (PDCO): 8-11 September 2026 Online European Medicines Agency, Amsterdam, the Netherlands Start date: 8 September 2026 End date: 11 September 2026

Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 September 2026

08 Sep 2026 Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 September 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 8 September 2026 End date: 10 September...

Committee for Orphan Medicinal Products (COMP): 8-10 September 2026

08 Sep 2026 Committee for Orphan Medicinal Products (COMP): 8-10 September 2026 European Medicines Agency, Amsterdam, the Netherlands Start date: 8 September 2026 End date: 10 September 2026

Ally Powder stoma powder included in high-cost protection

TLV approves Ally Powder stoma powder for inclusion in Sweden's high-cost protection scheme from 9 September 2026.

NovaLife 1 TRE Drainable Infant and NovaLife 1 TRE Drainable Micro included in pharmaceutical benefits

Two drainable one-piece stoma pouches for infants approved for inclusion in Swedish pharmaceutical benefits from 14 September 2026.

Eudralex Volume 4: Reference and Retention Samples (revised, applicable as of 24 September 2026)

Revised Eudralex Volume 4 guidance on reference and retention samples for medicinal products enters into force.

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date

FDA extends the effective date of the final resolution of Drug Efficacy Study Implementation 7661 for estrogen-androgen fixed-combination products to November 4, 2026.

Consultation on articles of the European Pharmacopoeia, Pharmeuropa 38.3

Current issue of Pharmeuropa (38.3) open for comment until 30 September 2026.

Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update

CMS updates IPF prospective payment rates, wage index, outlier thresholds, and implements standardized patient assessment for FY 2027.

Agenda: 40th meeting of the Expert Group on Health Systems Performance Assessment (1 October 2026)

News announcement 31 August 2026 Agenda - 40th meeting of the Expert Group on Health Systems Performance Assessment (1 October 2026) Agenda - 40th meeting of the Expert Group on Health Systems Perf...

List of interchangeable medicinal products, 1 October – 31 December 2026

Medical Device User Fee Rates for Fiscal Year 2027

FDA announces medical device user fee rates and payment procedures for FY 2027 (October 1, 2026 – September 30, 2027) under MDUFA V.

Medicaid Program; Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes

Proposed rule revising indirect hold harmless thresholds for health care-related taxes, effective October 1, 2026 and 2027, implementing the Working Families Tax Cut legislation.

Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update

CMS updates prospective payment rates, outlier thresholds, wage index, and quality reporting measures for inpatient psychiatric facilities effective October 1, 2026.

Obligation to submit a variation application following PSUSA procedure

10.03.2026

New portal makes it easier for companies to apply to the Danish Medicines Council

Medicinrådet launches a digital applicant portal on 5 October 2026 for companies to submit requests for assessment of new medicines for standard treatment in the Danish health system.

Remote and telephone appointments included in nurses' limited right to prescribe medicines

Nurses' limited prescribing authority now extends to remote and telephone appointments, effective 10 June 2026.

PRAC meeting highlights, 6–9 July 2026

PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata   Desogestrel- and etonogestrel-…, Age...

DCP (Latvia as RMS) and national registration procedures: time slot booking for 2027 opens 15 July 2026

Latvia ZVA opens booking for free time slots for medicine registration applications under DCP procedures and national procedures for 2027.

DHPC – Domperidon axapharm lingual®, Domperidon lingual Spirig HC®, Domperidon-Mepha® oro, Motilium®, Motilium lingual®, Motilium lingual Gastrosan® (Domperidon)

Direct Healthcare Professional Communication issued for domperidon-containing medicines regarding safety information.

Summary report on authorisation – Enflonsia®

Marketing authorisation granted for Enflonsia®.

Obligation to implement special quality control – veterinary medicinal products

Slovenia's food and veterinary authority imposed special quality control requirements for veterinary medicinal products on 10 July 2026.

SARAP 2026 Conference: Invitation - Module 2

Conference on medicine registration and pharmacovigilance activities, including changes to Slovak pharmaceutical legislation (Act 362/2011), scheduled 14 October 2026.

Stakeholder event on guidelines on the interplay between data protection and competition law

<p>Brussels, 30 July – The EDPB and the European Commission organise a remote stakeholder event in the context of their joint work on upcoming <strong>guidelines on the interplay between competitio...