Nested packaging for pharmaceutical products, and methods of distributing pharmaceutical products using same
A pharmaceutical product can be distributed to respective patients in a plurality of jurisdictions. First and second jurisdictions can have different labeling requirements than each other. A plurality of inner containers each store the pharmaceutical product, the pharmaceutical product being in a dosage form and in a package approved by each jurisdiction of the plurality. An inner container can be sealed within a first outer container including labeling required by the first jurisdiction and not required by the second jurisdiction. Another inner container can be sealed within a second outer container including labeling required by the second jurisdiction and not required by the first jurisdiction. The sealed first and second outer containers respectively can be distributed to the first and second jurisdictions.
1. Packaging for use in distributing a pharmaceutical product to respective patients in a plurality of jurisdictions, a first jurisdiction of the plurality of jurisdictions having a different labeling requirement for the pharmaceutical product than a second jurisdiction of the plurality of jurisdictions, the packaging comprising:
the pharmaceutical product;
a plurality of inner containers each storing the pharmaceutical product, the pharmaceutical product being in a dosage form and in a package approved by each jurisdiction of the plurality of jurisdictions;
a first one-piece outer container fully enclosing and sealing therein a first one of the plurality of inner containers storing the pharmaceutical product, the first outer container comprising a first label required by the first jurisdiction and not required by the second jurisdiction; and
a second one-piece outer container fully enclosing and sealing therein a second one of the plurality of inner containers storing the pharmaceutical product, the second outer container comprising a second label required by the second jurisdiction and not required by the first jurisdiction.
2. The packaging of claim 1 , wherein the dosage form is a pill, tablet, or capsule and the package comprises a blister pack.
3. The packaging of claim 1 , wherein each of the first and second outer containers comprises a folding box.
4. The packaging of claim 1 , further comprising:
sealed within the first outer container and outside of the first one of the inner containers a first leaflet approved by the first jurisdiction and not approved by the second jurisdiction; and
sealed within the second outer container and outside of the second one of the inner containers a second leaflet approved by the second jurisdiction and not approved by the first jurisdiction.
5. The packaging of claim 1 , further comprising a tamper seal sealing the pharmaceutical product within each of the inner containers.
6. The packaging of claim 1 , wherein the first one of the inner containers is sealed within the first outer container with a first tamper seal, and
wherein the second one of the inner containers is sealed within the second outer container with a second tamper seal.
7. The packaging of claim 1 , wherein the plurality of jurisdictions comprises member states of the European Union, the Middle East and North Africa, or Asia Pacific countries.
8. The packaging of claim 1 , wherein the pharmaceutical product includes pomalidomide, lenalidomide, or other commercial product.