Your Local Pharmacovigilance Partner for Drug Safety in Sweden
DDReg provides pharmacovigilance services in Sweden for pharmaceutical marketing authorisation holders (MAHs). Our team manages MPA pharmacovigilance obligations for nationally and centrally authorised products, operates local PV functions for foreign MAHs, coordinates EudraVigilance reporting, and delivers pharmacovigilance outsourcing Sweden mandates across the full post-marketing lifecycle.
Sweden Pharmacovigilance Framework
The Swedish Medical Products Agency (MPA; Läkemedelsverket) is Sweden's national competent authority for pharmacovigilance. Headquartered in Uppsala, the MPA is one of Europe's top three regulatory agencies by centralized procedure approval volume and holds strong representation in EMA PV committees including PRAC. Sweden implements the EU pharmacovigilance framework Directive 2001/83/EC as amended by Directive 2010/84/EU and Regulation (EC) No 726/2004, through the Medicinal Products Act (2015:315) and Regulation (2015:458).
No local contact person for pharmacovigilance (LCPPV) is legally required in Sweden. The EU QPPV residing in the EEA is sufficient. Foreign MAHs without Swedish PV operations may appoint a local contact voluntarily for Swedish-language communications, but this is not an MPA regulatory obligation. Uppsala hosts both the MPA and the Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre for International Drug Monitoring, which maintains VigiBase, the global adverse drug reaction database.
Pharmacovigilance Outsourcing Sweden - DDReg Services
-
PV System Operation and Adverse Event Reporting
-
Drug Safety Services Sweden - PSURs and Signal Management
-
MPA Inspection Readiness
Sweden Pharmacovigilance Reporting Timelines
| Obligation | Deadline | Route |
|---|---|---|
| Serious unexpected SADR (EEA) | 15 calendar days | EudraVigilance electronic submission |
| Non-serious ICSRs (EEA) | Within 90 days | EudraVigilance electronic submission |
| PSUR - EURD-listed substance | Per EURD list DLP | EMA PSUR Repository |
| PSUR - national | Per MA frequency | EMA PSUR Repository ('non-EU single assessment') |
| QPPV/PSMF location change | Immediately | Article 57 database |
Pharmacovigilance Company in Sweden - DDReg Expertise
Uppsala hosts both the MPA and the Uppsala Monitoring Centre, the WHO global pharmacovigilance hub. This co-location creates a regulatory environment where MPA expectations are informed by international best practice.
DDReg's Swedish PV operations align with this high-standard environment: audit-ready PSMF documentation, complete EudraVigilance case reporting, and signal management processes that anticipate both MPA and PRAC scrutiny.
Sweden does not legally require a local PV contact. The EU QPPV is sufficient. For MAHs that prefer Swedish-language MPA communications or want a Sweden-based PV function for operational efficiency, DDReg provides that contact voluntarily.
For medical device vigilance, where MPA e-services are Swedish-only, DDReg coordinates reporting on behalf of foreign manufacturers without Swedish operational presence.
MPA is among Europe's top three agencies by centralized procedure approvals and contributes assessors to multiple EMA committees.
Companies with MPA-authorised products benefit from an NCA that actively participates in PRAC signal assessments and EU safety referrals.
DDReg monitors MPA outputs - published assessment reports, safety communications, and PRAC voting records for signals affecting client products.
Global Reach Explorer
Find Your Solution
Select your region, country, and service type to discover regulatory & pharmacovigilance solutions.
Our Pharmacovigilance (PV) Services Expertise
ICSR Case Processing and Submission
Our advanced Individual Case Safety Report (ICSR) Pharmacovigilance Services are dedicated to ensuring patient safety through precise case handling....
Literature Monitoring
DDReg’s Literature Monitoring Services offer advanced pharmacovigilance literature screening for drug safety. We help Marketing...
Risk Management
Our expert risk management solutions ensure patient safety by proactively addressing potential hazards in pharmaceutical...
Audit and Compliance
Our specialized services ensure that pharmacovigilance systems across the drug development pipeline meet strict regulatory...
Pharmacovigilance Signal Management Services
DDReg’s specialized pharmacovigilance services ensure that potential adverse events are identified and addressed promptly...
QPPV Services
DDReg’s expert team provides comprehensive QPPV services designed to strengthen your pharmacovigilance system. We ensure that...
