MHRA wholesale authorisation roadmap
NovaPharm is preparing the governance, QMS, Responsible Person support and outsourced-activity controls required for a future WDA(H) application. No regulated wholesale supply will commence before authorisation.
Regulatory
Regulatory readiness before regulated activity.
NovaPharm's regulatory model connects authorisation, QMS, GDP, vendor evidence, pharmacovigilance and product lifecycle responsibilities.
Regulatory architecture
Permissions, procedures and evidence must agree.
NovaPharm's preparation model treats authorisation, product status, quality responsibilities and outsourced activities as connected controls, not independent workstreams.
Authorisation and accountable rolesProduct-specific pathway and evidenceQMS, GDP and vendor oversightSafety, recall and release controls
Controlled sequence
- 01Accountable roles
- 02Product evidence
- 03Vendor oversight
- 04Safety readiness
- 05Authorised release
Commercial release remains locked until the applicable company and product permissions are in place.
Product-specific PLPI pathway
Opportunities are assessed against the MHRA's simple, standard and complex categories, source-product evidence, UK cross-reference product, company functions, packaging, labelling, pharmacovigilance and recall obligations.
Quality Management System
The planned QMS covers policy and SOP governance, document control, training, deviations, CAPA, change control, complaints, audits, management review and data integrity.
Good Distribution Practice
Storage, transport, temperature controls, batch traceability, supplier qualification, quality agreements and oversight of outsourced activities form the planned GDP control framework.
Pharmacovigilance & recalls
Responsibilities, adverse-event intake, escalation, defect handling, recall readiness, documentation and regulatory communication must be established before relevant products are supplied.
Vendor qualification
Supplier licences, GMP/GDP standing, quality evidence, audit need, commercial scope and ongoing monitoring are reviewed for each proposed relationship.
Regulatory status
Company incorporation does not itself authorise pharmaceutical wholesale activity. NovaPharm's website distinguishes the active legal entity from licences and product approvals that remain in preparation or subject to grant.
Does NovaPharm currently hold a WDA(H)?
NovaPharm does not publish a claim that it holds a WDA(H). The company is preparing its operating and quality systems and will not commence regulated wholesale supply until the required authorisation is in place.
Does NovaPharm hold PLPI product licences?
No product-specific PLPI licence is represented as granted on this website. PLPI is a strategic pathway under regulatory preparation and each product would require the applicable MHRA approval.
Can a third-party logistics provider carry all regulatory responsibility?
No. Outsourced providers perform agreed activities, while the pharmaceutical company must define, qualify and oversee the relationship and retain its applicable responsibilities.